Overmolded Hemolysis Reduction Accessories for Direct Blood Collection

Abstract

The flow restrictor device includes 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 lumen and the second lumen. The third lumen has a diameter of less than 0.025 inches. The overmolded body portion is formed around the tube.

Description

[Technical field]

[0001] The present disclosure relates generally to blood collection and administration of parenteral fluids to a patient, and more particularly to systems and methods for reducing hemolysis in PIVC blood collection using an overmolded flow restrictor device. [Background technology]

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

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

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

[0005] A blood collection container may be used to draw blood from a patient or to collect a blood sample from a patient. The blood collection container may include a syringe. Alternatively, the blood collection container may include a test tube with a rubber stopper at one end. In some cases, the test tube has had all or a portion of the air removed from the test tube so that the pressure within the test tube is less than the ambient pressure. Such blood collection containers are often referred to as 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 coupled to the catheter. When the blood collection container is coupled to the catheter, the pressure in the vein is greater than the pressure in the blood collection container. This forces blood into the blood collection container, causing it to fill with blood. The vacuum in the blood collection container decreases as the blood collection container fills, and blood flow stops when the pressure in the blood collection container equals the pressure in the vein.

[0007] Unfortunately, when blood is collected into the blood collection container, the high initial pressure difference between the vein and the blood collection container places red blood cells in a state of high shear stress, which makes them susceptible to hemolysis. Hemolysis can lead to rejection and discarding of the blood sample. The high initial pressure difference can also lead to collapse of the catheter tip, collapse of the vein, or other problems that prevent or limit the blood from filling the blood collection container. Additionally, blood spillage commonly occurs during and / or after blood collection.

[0008] A statement made in the Background section should not be considered prior art merely because it is mentioned in the Background section or merely because it is associated with the Background section. The Background section may include information that describes one or more aspects of the subject technology. Summary of the Invention [Means for solving the problem]

[0009] The present disclosure provides a flow restrictor 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 in fluid communication with the first lumen and the second lumen, the third lumen having a diameter of less than 0.635 mm (0.025 inches), the flow restrictor device further comprising an overmolded body portion formed around the tube.

[0010] In some instances, the present disclosure provides a method of manufacturing a flow restrictor device, comprising the steps of providing a tube, the tube defining a lumen having a diameter of less than 0.025 inches, and molding an overmolded body portion over the tube.

[0011] In some embodiments, the present 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 end and a distal end, a fluid collection device, and a flow restriction device, the flow restriction device having a male luer connector portion coupled to the catheter hub and defining a first lumen, a female luer connector portion defining a second lumen in fluid communication with the fluid collection device, and a tube defining a third lumen, the third lumen in fluid communication with the first lumen and the second lumen, the third lumen having a diameter of less than 0.635 mm (0.025 inches), and the flow restriction device further comprising an overmolded body portion formed around the tube.

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

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

[0014] [Figure 1] 1 illustrates a vascular access device including a peripheral intravenous catheter (PIVC) assembly including a flow restriction device, according to some embodiments of the present disclosure. [Diagram 2] FIG. 2 illustrates a perspective view of a flow restrictor device according to some embodiments of the present disclosure. [Diagram 3] 3 illustrates an exploded perspective view of the flow restrictor of FIG. 2 according to some embodiments of the present disclosure. [Figure 4] 3 illustrates a cross-sectional view of the flow restrictor of FIG. 2 according to some embodiments of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

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

[0016] It should be understood that the present disclosure includes examples of the subject technology and does not limit the scope of the appended claims. Various aspects of the subject technology will now be disclosed by way of specific examples, but not by way of limitation. Various embodiments described in the present disclosure can be implemented in different ways and modifications and depending on the desired application or implementation.

[0017] Blood collection via vascular access devices has been gaining increasing attention due to the minimization of needle sticks and improved operational efficiency compared to traditional blood collection by venipuncture. Current blood collection using peripheral intravenous catheters (PIVCs) encounters several challenges, one of the most critical being blood quality related to hemolysis. In particular, the shear stress acting on blood cells by the current PIVC products on the market with standard connections (such as short extension sets and needleless connectors) and blood collection devices (such as vacutainers) can easily lead to near hemolysis.

[0018] Various embodiments of the present disclosure are directed to providing systems and methods for addressing hemolysis in PIVC blood collection with a hemolysis reduction accessory (also referred to herein as a flow restrictor) that is pre-attached to the PIVC and acts as a flow restrictor to reduce the risk of hemolysis. The hemolysis reduction accessory is advantageously compatible with PIVC configurations and does not require any modifications to current operations. The hemolysis reduction accessories of various embodiments described herein are potentially applicable to a wide variety of PIVC products and are compatible with current blood collection devices and infusion disposables.

[0019] Various embodiments of the present disclosure focus on effective flow restriction with an add-on hemolysis reduction accessory (also referred to herein as a flow restrictor), which regulates the overall flow rate of the entire fluid path through which blood cells travel. The flow restrictor may be assembled with the PIVC or may be co-packaged with the PIVC. The clinician can connect a blood collection device to the port of the accessory and then draw blood into the volume of interest. After blood collection, the clinician can disconnect and discard the flow restrictor and blood collection device together. Thus, this flow restrictor may be for a single blood draw or may remain in-line throughout the entire placement.

[0020] The flow restriction devices and associated blood collection systems of the various embodiments described herein provide additional advantages over currently existing blood collection systems. For example, the add-on flow restriction devices described herein allow for the integration of hemolysis reduction functionality for PIVC blood collection. Furthermore, the flow restriction devices described herein are compatible with PIVC placement, allowing seamless blood collection upon insertion. Moreover, because the flow restriction devices are add-on, they can be easily integrated into current PIVCs without any modifications, with minimal impact on the clinical environment and operation.

[0021] FIG. 1 illustrates a vascular access device 10 including a peripheral intravenous catheter (PIVC) assembly 50 including a flow restriction device 100, according to some embodiments of the present disclosure. The flow restriction device 100 can be configured to reduce the likelihood 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 further include a catheter 58, which can be secured within 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).

[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 that extends from and is integrated with a 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, for example, a Y-adapter 70. In some embodiments, the flow restrictor 100 may be fluidly coupled to the Y-adapter 70.

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

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

[0025] 2-4 with continued reference to FIG. 1, in some embodiments, the flow restriction device 100 may include a male luer connector portion 110 configured to couple to a catheter assembly 50. The male luer connector portion 110 may have an interior 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 proximally relative 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 integral with the blood collection device 40 or may be integrally formed with the blood collection device 40 as a single unit or portion. 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 a male luer portion of the blood collection device 40. The female luer connector portion 130 may include an interior surface 132 defining a lumen 136 extending 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 tubing 140 of the flow restriction device 100, as will be described below.

[0026] In the illustrated embodiment, the flow restriction device 100 includes a tube 140 extending longitudinally therethrough and in fluid communication with 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 along which fluid can flow from the male luer connector portion 110, via the female luer connector portion 130, and into the fluid collection device 40. As shown, the tube 140 can place the catheter assembly 50 in fluid communication with the fluid collection device 40 via the flow restriction device 100. For example, in some embodiments, the leg 72 of the Y-adapter 70 can be coupled to the flow restriction device 100. The leg 72 of the Y-adapter 70 can include a lumen into which the distal end of the male luer connector portion 110 can be coupled. The Y-adapter 70 can fluidly connect the flow restriction device 100 via connector 90, shown as a needleless connector, and the tubing 140 to the catheter assembly 50, for example, via extension tubing 60. The microchannel 142 can thus define a fluid path with a reduced, small, or micro-sized diameter (described below) through which fluid entering the flow restriction device 100 from the catheter assembly 50 can flow through the flow restriction device 100 for collection into the fluid collection device 40. For example, the medical fluid can be blood and the fluid collection device 40 can be a blood collection device where blood is being drawn or collected from a patient. In some embodiments, the blood collection device can be a Luer Lock Access Device (LLAD). Thus, during collection or withdrawal of blood from a patient, a blood sample can flow from the distal end of the male Luer connector portion 110 into the LLAD 40 via the flow path, or microchannel 142, defined by the tubing 140.

[0027] In some embodiments, the microchannel 142 defined by the tube 140 may be an elongated, narrow channel having a small, reduced, or micro-sized diameter. For example, in some embodiments, the tube 140 defining the flow path or microchannel along which fluid may flow from the male luer connector portion 110 into the fluid collection device 40 may have a diameter ranging from 20,000ths to 25,000ths of an inch. However, various embodiments of the present disclosure are not limited to the foregoing configurations. In some embodiments, the length of the microchannel 142 may range from 1 inch to 1.3 inches. Thus, during blood collection or withdrawal from a patient, blood 15 may flow into the blood collection device 40 via the flow path or microchannel defined by the microchannel 142 having the smallest diameter. The flow restriction device 100 of various embodiments described herein is advantageous over existing blood collection systems. For example, during blood collection in existing blood collection devices, blood cells may experience wall shear stress as they flow from the distal end to the proximal end of the blood collection system. Wall shear stress on blood cells is believed to be the primary source of mechanical damage to blood cells that causes hemolysis of the blood cells. With a microchannel 142 having a minimal diameter, increased flow resistance within the vascular access system may facilitate dispersing pressure differences and reducing shear stress experienced by red blood cells of blood 15. For example, the minimized diameter of microchannel 142 may provide increased resistance to the flow of blood 15, thereby reducing blood flow rate within flow restrictor 100. The risk of hemolysis during blood collection may be advantageously reduced since the reduced blood flow rate results in reduced shear stress experienced by red blood cells of blood 15. Additionally, the geometry of microchannel 142 may reduce the amount of blood wasted by existing blood collection systems.

[0028] According to various embodiments of the present disclosure, the flow restrictor 100 may further include a body portion 120 overmolded onto the tube 140 and extending between the male luer 110 portion and the female luer portion 130 .

[0029] According to various embodiments of the present disclosure, the exterior surface 122 of the body portion 120 may include a plurality of laterally extending ribs disposed about and surrounding the longitudinal axis of the body portion 120. As shown, the plurality of laterally extending ribs may be spaced apart from one another along the longitudinal axis X between the female luer connector portion 130 and the male luer connector portion 110. In some embodiments, the exterior surface 122 may further include at least one longitudinally extending rib disposed 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 FIG. 2, the body portion 120 may include a pair of longitudinally extending ribs disposed on opposing sides of the body portion 120. As shown, the longitudinally extending ribs may be disposed transversely to each of the laterally extending ribs and may be interconnected with each of the laterally extending ribs. Thus, a plurality of laterally extending ribs and one or more longitudinally extending ribs may form a grid or matrix configuration surrounding body portion 120 .

[0030] The grid or matrix configuration surrounding body portion 120 may advantageously provide additional or improved structural integrity or rigidity as compared to existing connectors for blood collection systems. For example, in some embodiments, the grid or matrix configuration of transversely and longitudinally extending ribs surrounding body portion 120 may increase rigidity between male luer connector portion 110 and female luer connector portion 130 of flow restrictor 100, thereby making flow restrictor 100 less susceptible to bending or twisting forces. The foregoing configuration is advantageous in that the increased rigidity of flow restrictor 100 reduces the flexibility of flow restrictor 100, thereby reducing the likelihood of blood spillage due to accidental or inadvertent bending or twisting of flow restrictor 100. Additionally, the above-described configuration of the flow restrictor including laterally extending ribs and longitudinally extending ribs surrounding the body portion 120 may be advantageous in that it provides a surface on the body portion that is easier to grip than if the gripping surface of the body portion 120 were 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 can further extend over a portion of the male luer connector portion 110 and / or the female luer connector portion 130. Advantageously, by overmolding the body portion 120, the flow restrictor 100 can provide a gripping surface for the clinician while reducing the manufacturing complexity of the flow restrictor 100. For example, the body portion 120 can be molded directly onto the top surface of the tube 140 to create a single part including the tube 140 and the body portion 120. Advantageously, the body portion 120 can define a simplified profile to simplify the overmolding process. In some embodiments, the body portion 120 can utilize a polymeric or elastomeric material. The above configuration in which the flow restrictor 100 is formed by an overmolded body simplifies the manufacturing process while allowing for a robust construction of the flow restrictor 100.

[0032] Description of the subject technology as a clause The subject technology is described according to various aspects, for example, as set forth below. Various examples of the aspects of the subject technology are described as numbered clauses (1, 2, 3, etc.) for convenience. These are provided as examples and not as limitations of the subject technology. Note that any of the dependent clauses can be combined in any combination and placed into their own independent clause, e.g., clause 1 or clause 5. Other clauses can be presented in a similar manner.

[0033] Clause 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 a tube defining a third lumen, the third lumen being in fluid communication with the first lumen and the second lumen, the third lumen having a diameter of less than 0.635 mm (0.025 inches), the flow restriction device further comprising an overmolded body portion formed around the tube.

[0034] Clause 2: A flow restrictor as in clause 1, wherein the third lumen has a length between 25.4 mm (1 inch) and 33.02 mm (1.3 inches).

[0035] Clause 3: The flow restrictor of clause 1, wherein the third lumen is configured to increase flow resistance through the third lumen to minimize shear stress experienced by the fluid flow.

[0036] Clause 4: The flow restrictor of clause 1, wherein the overmolded body portion extends over a portion of the male luer connector portion.

[0037] Clause 5: The flow restriction device of clause 1, wherein the overmolded body portion extends over a portion of the female luer connector portion.

[0038] Clause 6: The flow restricting device of clause 1, 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.

[0039] Clause 7: The flow restrictor of clause 6, wherein the first material comprises an elastomeric material or a polymeric material.

[0040] Clause 8: A flow restriction device of clause 1, wherein an outer surface of the overmolded body portion includes a plurality of laterally extending ribs arranged about and circumferentially surrounding a longitudinal axis of the overmolded body portion, the plurality of ribs being spaced apart from one another along the longitudinal axis between the female luer connector portion and the male luer connector portion.

[0041] Clause 9: A flow restriction device as in clause 8, wherein the outer surface of the overmolded body portion further includes at least one longitudinally extending rib disposed along the longitudinal axis and extending from the male luer connector portion to the female luer connector portion.

[0042] Clause 10: A method of manufacturing a flow restrictor, comprising the steps of: A method comprising the steps of providing a tube, the tube defining a lumen having a diameter of less than 0.025 inches (0.635 mm), and molding an overmolded body portion over the tube.

[0043] Clause 11: The method of clause 10, 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.

[0044] Clause 12: The method of clause 11, wherein the first material comprises an elastomeric or polymeric material.

[0045] Clause 13: A peripheral intravenous catheter assembly configured to limit hemolysis during blood withdrawal from a patient, 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 having a male luer connector portion coupled to the catheter hub and defining a first lumen, a female luer connector portion defining a second lumen in fluid communication with the fluid collection device, and a tube defining a third lumen, the third lumen in fluid communication with the first lumen and the second lumen, the third lumen having a diameter of less than 0.635 mm (0.025 inches), the flow restriction device further having an overmolded body portion formed around the tube.

[0046] Clause 14: The peripheral intravenous catheter assembly of clause 13, wherein the third lumen 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 flow resistance through the third lumen to minimize shear stress experienced by the fluid flow.

[0048] Clause 16: The peripheral intravenous catheter assembly of clause 13, wherein the overmolded body portion extends over a portion of the male luer connector portion.

[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: The peripheral intravenous catheter assembly of 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 comprises an elastomeric material or a polymeric material.

[0052] Clause 20: A peripheral intravenous catheter assembly of clause 13, wherein an outer surface of the overmolded body portion includes a plurality of laterally extending ribs disposed about and circumferentially surrounding a longitudinal axis of the overmolded body portion, the plurality of ribs being spaced apart from one another 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 aspects described herein. This disclosure provides various examples of the subject technology, but the subject technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects.

[0054] Reference to an element in the singular is not intended to mean "one of" unless specifically stated so, but rather "one or more." The term "some" refers to one or more, unless specifically stated otherwise. Masculine (e.g., his) pronouns include feminine and neuter (e.g., her and its) and vice versa. Headings and subheadings, if any, are used for convenience only and do not limit the invention.

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

[0056] As used herein, the phrase "at least one of" preceding a list of items modifies the list as a whole, rather than each item in the list, with the term "or" separating 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 including at least one item of any of the items, and / or at least one combination of any combination of the items, and / or at least one item of each of the items. Illustratively, the phrase "at least one of A, B, or C" can refer to only A, only B, or only C, or any combination of A, B, and C.

[0057] A phrase such as "aspect" does not imply that such aspect is essential to the subject technology, nor that such aspect applies to all configurations of the subject technology. A disclosure of an aspect may apply to all configurations, or to one or more configurations. An aspect may provide one or more examples. A phrase such as an aspect may refer to one or more aspects, and vice versa. A phrase such as "embodiment" does not imply that such an embodiment is essential to the subject technology, nor that such an embodiment applies to all configurations of the subject technology. A disclosure of an embodiment may apply to all embodiments, or to one or more examples. An embodiment may provide one or more examples. A phrase such as an embodiment may refer to one or more examples, and vice versa. A phrase such as "configuration" does not imply that such an embodiment is essential to the subject technology, nor that such an embodiment applies to all configurations of the subject technology. A disclosure of a configuration may apply to all configurations, or to one or more configurations. A configuration may provide one or more examples. A phrase such as a configuration can refer to one or more configurations, and vice versa.

[0058] In one aspect, unless otherwise stated, all measurements, values, ratings, locations, dimensions, sizes, and other specifications set forth herein, including those in the claims that follow, are approximate and not exact, and are intended to have a reasonable range consistent with the functions to which they relate and with what is customary in the art to which they pertain.

[0059] It is understood that the specific order or hierarchy of steps or operations in the disclosed processes or methods is an illustration of an example approach. It is understood that the specific order or hierarchy of steps, operations or operations may be rearranged based on implementation preferences or scenarios. Some of the steps, operations or operations may be performed simultaneously. In some implementation preferences or scenarios, certain operations may or may not be performed. Some or all of the steps, operations or operations may be performed automatically without user intervention. The accompanying method claims present elements of the various steps, operations or processes in a sample order, and are not meant to be limited to the specific order or hierarchy presented.

[0060] All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or that later become known to those skilled in the art are intended to be expressly incorporated herein by reference and encompassed by the claims. Moreover, nothing disclosed herein is intended to be made available to the public, regardless of whether such disclosure is explicitly set forth in the claims. No element of a claim is to be construed under the provisions of 35 U.S.C. 112(f) unless the element is expressly recited using the phrase "means for" or, in the case of a method claim, unless the element is recited using the phrase "step for". Furthermore, to the extent the terms "comprise", "have", and the like are used, such terms are intended to be inclusive in the same manner as the term "comprise", as "comprise" is interpreted when used as a transitional word in a claim.

[0061] The title, background, summary, brief description of the drawings, and abstract of this disclosure are hereby incorporated into this disclosure and are provided as illustrative examples of this disclosure and not as a limiting description. This disclosure is submitted with the understanding that they are not used to limit the scope or meaning of the claims. Furthermore, it can be understood that in the detailed description, the description provides illustrative examples, and that various features have been grouped together in various embodiments to streamline the disclosure. This method of disclosure should not be interpreted as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed structure or operation. The following claims are hereby incorporated into the detailed description, with each claim standing on its own as separately claimed subject matter.

[0062] The claims are not intended to be limited to the embodiments described herein, but are to be accorded full scope consistent with the language of the claims and include all legal equivalents. However, none of the claims are intended, and should not be construed, to cover subject matter that does not comply with the requirements of 35 U.S.C. §§ 101, 102, or 103.

Claims

1. a male luer connector portion defining a first lumen; a female luer connector portion defining a second lumen; a tube defining a third lumen, the third lumen in fluid communication with the first lumen and the second lumen, the third lumen having a diameter of less than 0.025 inches, the flow restriction device further comprising: A flow restrictor comprising an overmolded body portion formed about the tube.

2. 10. The flow restriction device of claim 1, wherein the third lumen has a length of between 1 inch and 1.3 inches.

3. The flow restriction device of claim 1 , wherein the third lumen is configured to increase flow resistance therethrough to minimize shear stress experienced by the fluid flow.

4. The flow restricting device of claim 1 , wherein the overmolded body portion extends over a portion of the male luer connector portion.

5. The flow restricting device of claim 1 , wherein the overmolded body portion extends over a portion of the female luer connector portion.

6. 10. The flow restricting device of claim 1, 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.

7. The flow restricting device of claim 6 , wherein the first material comprises an elastomeric or polymeric material.

8. 2. The flow restricting device of claim 1, wherein an outer surface of the overmolded body portion includes a plurality of laterally extending ribs disposed about and circumscribing a longitudinal axis of the overmolded body portion, the plurality of ribs being spaced apart from one another along the longitudinal axis between the female luer connector portion and the male luer connector portion.

9. 9. The flow restricting device of claim 8, wherein the outer surface of the overmolded body portion further includes at least one longitudinally extending rib disposed along the longitudinal axis and extending from the male luer connector portion to the female luer connector portion.

10. 1. A method of manufacturing a flow restrictor, comprising: providing a tube, the tube defining a lumen having a diameter of less than 0.025 inches; and molding an overmolded body portion over said tube.

11. The method of claim 10 , 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.

12. The method of claim 11 , wherein the first material comprises an elastomeric or polymeric material.

13. 1. A peripheral intravenous catheter assembly configured to limit hemolysis during blood withdrawal from a patient, comprising: a catheter hub having a proximal end and a distal end; A fluid collection device; a flow restriction device, a male luer connector portion coupled to the catheter hub and defining a first lumen; a female luer connector portion defining a second lumen in fluid communication with the fluid collection device; a tube defining a third lumen, the third lumen in fluid communication with the first lumen and the second lumen, the third lumen having a diameter of less than 0.025 inches, the flow restrictor further comprising: A peripheral intravenous catheter assembly having an overmolded body portion formed about said tube.

14. 14. The peripheral intravenous catheter assembly of claim 13, wherein the third lumen has a length of 1 inch to 1.3 inches.

15. 14. The peripheral intravenous catheter assembly of claim 13, wherein the third lumen is configured to increase flow resistance therethrough to minimize shear stress experienced by the fluid flow.

16. The peripheral intravenous catheter assembly of claim 13, wherein the overmolded body portion extends over a portion of the male luer connector portion.

17. The peripheral intravenous catheter assembly of claim 13 , wherein the overmolded body portion extends over a portion of the female luer connector portion.

18. 14. The peripheral intravenous catheter assembly of claim 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.

19. 20. The peripheral intravenous catheter assembly of claim 18, wherein the first material comprises an elastomeric or polymeric material.

20. 20. The peripheral intravenous catheter assembly of claim 18, wherein an outer surface of the overmolded body portion includes a plurality of transversely extending ribs disposed about and circumferentially about a longitudinal axis of the overmolded body portion, the plurality of ribs being spaced apart from one another along the longitudinal axis between the female luer connector portion and the male luer connector portion.

Images