Hemolysis-reduction accessories for direct blood draw

Abstract

To provide a flow restriction device.SOLUTION: A flow restriction device may include a housing with first and second end portions forming respective first and second openings, and a cavity configured to receive an insert body defining a fluid passage that extends from a first opening of the housing at the first end portion to a second opening of the housing at the second end portion, where the fluid passage extends in more than one direction along a path between the first and second end portions of the housing to induce a resistance to a fluid flow moving through the device, thereby reducing a flow rate and pressure of the fluid, and where the fluid is blood, reducing the hemolysis index of the blood.SELECTED DRAWING: Figure 3

Description

[Technical Field]

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 293,489, filed December 23, 2021, entitled "HEMOLYSIS-REDUCTION ACCESSORIES FOR DIRECT BLOOD DRAW," the disclosure of which is incorporated herein by reference in its entirety.

[0002] The present disclosure relates generally to blood collection and administration of parenteral fluids to patients, and more particularly to systems and methods for reducing hemolysis in PIVC blood collection using a flow restrictor device. [Background technology]

[0003] Catheters are commonly used for a variety of infusion therapies. For example, catheters can be used to infuse fluids, such as saline, various medications, and complete parenteral diets, into a patient. Catheters can also be used to withdraw blood from a patient.

[0004] A common type of catheter is the through-the-needle peripheral intravenous ("IV") catheter (PIVC). As the name suggests, a through-the-needle catheter may be mounted over an introducer needle with a sharp distal tip. The catheter assembly may include a catheter hub, a catheter extending distally from the catheter hub, and an introducer needle extending through the catheter. The catheter and introducer needle may be assembled such that the bevel of the introducer needle points up, away from the patient's skin, and the distal tip of the introducer needle extends beyond the distal tip of the catheter. The catheter and introducer needle are generally inserted at a shallow angle through the skin into the patient's vasculature.

[0005] To verify proper placement of the introducer needle and / or catheter within the blood vessel, clinicians 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.

[0006] A blood collection container may be used to withdraw 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 it so that the pressure within the tube is less than 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.

[0007] A blood collection container may be coupled to the catheter. When the blood collection container is coupled to the catheter, the pressure in the vein is greater than the pressure in the blood collection container, forcing blood into the blood collection container, which then fills with blood. The vacuum in the blood collection container decreases as the blood collection container fills, until the pressure in the blood collection container equals the pressure in the vein and blood flow stops.

[0008] Unfortunately, when blood is drawn into a blood collection container, the high initial pressure difference between the vein and the blood collection container places red blood cells in a state of high shear stress, making them susceptible to hemolysis. Hemolysis can lead to rejection and discarding of the blood sample. The high initial pressure difference can also lead to collapsed catheter tips, collapsed veins, or other problems that prevent or restrict blood from filling the blood collection container. Additionally, blood spillage commonly occurs during and / or after blood collection.

[0009] A statement made in the Background Art section should not be considered prior art merely because it is mentioned in or associated with the Background Art section. The Background Art section may include information that describes one or more aspects of the subject technology. Summary of the Invention [Means for solving the problem]

[0010] The present disclosure provides a flow restrictor device comprising a housing and an insert body, the housing having a first end portion, a second end portion, an inner surface forming a cavity between the first end portion and the second end portion, a first opening through the first end portion, and a second opening through the second end portion, the insert body having a first end, a second end, a longitudinal axis extending through the first and second ends, and an inner surface forming a fluid passage extending between the first end and the second end, the fluid passage having a first portion extending in a first direction away from the longitudinal axis, a second portion extending in a second direction toward the longitudinal axis, and a third portion extending in the first direction, the insert body being positioned within the cavity with the first opening of the fluid passage fluidly coupled with the first opening of the housing and the second opening of the fluid passage fluidly coupled with the second opening of the housing.

[0011] In some cases, the disclosure provides a flow restrictor device comprising a housing and an insert body, the housing having a first end portion, a second end portion, an inner surface forming a cavity between the first end portion and the second end portion, a first opening through the first end portion, and a second opening through the second end portion, the insert body having a first end, a second end, an outer surface extending between the first end and the second end, and an inner surface forming a fluid passage extending between the first end and the second end, the fluid passage having a first opening through the first end of the insert body, a second opening through the second end of the insert body, and a third opening through the outer surface, the insert body being positioned within the cavity with the first opening of the fluid passage fluidly coupled to the first opening of the housing, the second opening of the fluid passage fluidly coupled to the second opening of the housing, and the third opening blocked by the inner surface of the housing.

[0012] In some instances, the present disclosure provides a peripheral intravenous catheter assembly configured to limit hemolysis during blood collection from a patient, the peripheral intravenous catheter assembly including a flow restrictor, a catheter hub, and a fluid connector, the flow restrictor having a housing and an insertion body, the housing having a first end portion, a second end portion, an interior surface forming a cavity between the first end portion and the second end portion, and a first opening through the first end portion, the first end portion configured to be coupled to a catheter assembly, and the second end portion configured to be coupled to a fluid collection device, the insertion body having a first end, a second end, a longitudinal axis extending through the first and second ends, and a the fluid passage has a first portion extending in a first direction away from the longitudinal axis, a second portion extending in a second direction toward the longitudinal axis, and a third portion extending in the first direction; an insertion body is positioned within the cavity from the first end portion of the housing through the second end portion of the housing with a first opening of the fluid passage fluidly coupled with the first opening of the housing and a second opening of the fluid passage fluidly coupled with the second opening of the housing to limit hemolysis of blood drawn from the patient into the fluid collection device; a catheter hub has a proximal end and a distal end; and a fluid connector fluidly couples the catheter hub to the flow restriction device.

[0013] 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.

[0014] 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, permutation, combinations, and equivalents in form and function that will occur to those skilled in the art and having the benefit of this disclosure. [Brief explanation of the drawings]

[0015] [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. [Figure 2] FIG. 1 illustrates a perspective view of a flow restrictor device, according to some embodiments of the present disclosure. [Figure 3] 3 illustrates an exploded view of the flow restrictor of FIG. 2 according to some embodiments of the present disclosure. [Figure 4] 1A and 1B show perspective views of an insert body for a flow restrictor device according to some embodiments of the present disclosure. [Figure 5A] 5 illustrates a cross-sectional view of the flow restrictor of FIG. 2 taken along line 5-5, according to some embodiments of the present disclosure. [Figure 5B] 5 illustrates another cross-sectional view of the flow restrictor of FIG. 2 taken along line 5-5, according to some embodiments of the present disclosure. [Figure 6] FIG. 1 illustrates a perspective view of a flow restrictor device according to some embodiments of the present disclosure. [Figure 7] FIG. 1 illustrates a perspective view of an insert body for a flow restrictor device, according to some embodiments of the present disclosure. [Figure 8] 1A and 1B illustrate cross-sectional views of a flow restrictor device according to some embodiments of the present disclosure. [Figure 9] FIG. 1 illustrates a perspective view of an insert body for a flow restrictor device, according to some embodiments of the present disclosure. [Figure 10] 1A and 1B illustrate cross-sectional views of a flow restrictor device according to some embodiments of the present disclosure. [Figure 11] 1A-1C illustrate cross-sectional views of an insert body for a flow restrictor device according to some embodiments of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0016] 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 to achieve 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.

[0017] It should be understood that the present disclosure includes examples of the subject technology and is not intended to 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. The various embodiments described in this disclosure can be implemented in different ways and variations and depending on the desired application or implementation.

[0018] Blood collection via vascular access devices has attracted increasing attention due to the minimized needle stick 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 significant being blood quality related to hemolysis. In particular, the shear stress acting on blood cells by PIVC products currently on the market with standard connections (such as short extension sets and needleless connectors) and blood collection devices (such as vacutainers) tends to be on the verge of hemolysis.

[0019] Various embodiments of the present disclosure are directed to providing systems and methods for addressing hemolysis in PIVC blood collection using a hemolysis reduction accessory (also referred to herein as a flow restrictor) that can be pre-attached to a PIVC and reduce flow rates 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.

[0020] Various embodiments of the present disclosure focus on effective flow reduction using 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 or co-packaged with the PIVC. Thus, the device can tolerate blood flashback without further manipulation during catheter placement. The clinician can retrieve a blood collection device into a port or opening in 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 can be for a single blood draw or can remain in-line throughout the entire placement.

[0021] The flow restrictor devices and associated blood collection systems of various embodiments described herein provide additional advantages over currently existing blood collection systems. For example, the add-on flow restrictor devices described herein allow for the integration of hemolysis reduction functionality for PIVC blood collection. Furthermore, the flow restrictor devices described herein are compatible with PIVC placement, allowing for seamless blood collection during insertion. Furthermore, because the flow restrictor devices are add-on, they can be easily integrated into existing PIVCs without any modifications, with minimal impact on the clinical environment and operation.

[0022] 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 and proximal ends. 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).

[0023] In some embodiments, catheter assembly 50 may include or correspond to any suitable catheter assembly 50. In some embodiments, catheter assembly 50 may be integrated and include extension tube 60, which may extend from and be integrated with side port 59 of 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 extension tube 60 may be coupled to an adapter, such as, for example, a Y-adapter 70. In some embodiments, flow restrictor 100 may be fluidly coupled to Y-adapter 70.

[0024] 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 restrictor 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 restrictor 100 may be coupled directly to the catheter assembly 50, thereby eliminating the extension tube 60 and providing a compact catheter system.

[0025] Figure 2 shows a perspective view of a flow restrictor 100 according to some embodiments of the present disclosure. Figure 3 shows an exploded view of the flow restrictor 100 having a housing including a first end portion and a second end portion and an insert body. Figure 4 shows a perspective view of the insert body 106 of Figure 3. Figures 5A and 5B show cross-sectional views of the flow restrictor 100 of Figure 2 taken along line 5-5.

[0026] 2-5B, with continued reference to FIG. 1, in some embodiments, flow restrictor 100 includes a housing 148 having a first end portion 150 and a second end portion 110. First end portion 150 can be configured to couple to catheter assembly 50, and second end portion 110 can be configured to couple to a fluid collection device, such as blood collection device 40.

[0027] For example, second end portion 110 may be integral with blood collection device 40 or may be integrally formed with blood collection device 40 as a single unit or portion. As another example, second end portion 110 may be in the form of a female luer connector or another suitable connector that can mate with a male luer portion of blood collection device 40. Additionally, first end portion 150 may be in the form of a male luer connector or another suitable connector that can mate with a catheter or portion of a catheter assembly.

[0028] First end portion 150 can have an interior surface 156 that forms a first opening 154. Second end portion 110 can include an interior surface 115 that forms a second opening 114 extending therethrough for coupling to a male luer portion of blood collection device 40. Second end portion second opening 114 can be fluidly connected to first end portion first opening 154 through cavity 140 formed by the interior surface of the housing.

[0029] In some embodiments of the present disclosure, the first end portion 150 of the housing can be formed as either a male and / or female luer connector having a first opening 154 extending therethrough, and the second end portion 110 of the housing can be formed as the other of a male and / or female luer connector having a second opening 114 extending therethrough. The housing 148 can comprise a material including a thermoplastic polymer, such as polycarbonate or another material having similar properties.

[0030] According to various embodiments of the present disclosure, the first end portion 150 can be integrally formed with the housing 148 to form a single, unitary part, and the housing 148 can be coupled to the second end portion 110. When the first and second end portions 150, 110 are assembled or integrally formed, the first opening 154 of the first end portion is fluidly coupled to the second opening of the second end portion through the cavity 140.

[0031] The cavity 140 is configured to receive the insert body 106 therein. The insert body 106 guides fluid flow between the first opening 154 and the second opening 114 of the housing while inducing resistance to the fluid flow as the fluid moves through the insert body 106. By inducing resistance to fluid flow, the velocity of the fluid flow is reduced as the fluid moves through the insert body 106. By reducing the flow rate of a fluid, such as blood, through the flow restrictor 100, the hemolytic index of the blood can be reduced.

[0032] The insert body 106 has a first end 164, a second end 166, and an inner surface 168 that defines a fluid passageway 170 that extends through the first and second ends 164, 166. The fluid passageway 170 extends along a path between the first and second ends 164, 166 of the body and is configured to reduce the velocity of fluid flow through the insert body 106. A perspective view of the insert body 106 is shown in FIG. 4, where the transparent depiction of the body allows visualization of the fluid passageway 170 in connection with the present disclosure.

[0033] In some embodiments of the present disclosure, the inserter body first end 164 and the inserter body second end 166 form the proximal-most and distal-most surfaces of the body, respectively. The inserter body 106 can further define a longitudinal axis A1 extending through the first and second ends 164, 166. The fluid passageway 170 spans between the inserter body first end 164 and the second end 166 and is configured to extend in two or more directions along a path between the first end 164 and the second end 166. Because the path extends in two or more directions, the fluid passageway 170 extends indirectly between the inserter body first end 164 and the second end 166. The indirect path between the body first end 164 and the second end 166 can have a length greater than the distance between the body first end 164 and the second end 166.

[0034] The fluid passageway 170 includes a first opening 180 through the first end 164 of the insert body and a second opening 182 through the second end 166 of the insert body. Between the first opening 180 and the second opening 182, the fluid passageway 170 may include a third opening 184 through the outer surface 186 of the insert body. The third opening 184 extends through the outer surface 186 at a location between the first end 164 and the second end 166. The location of the third opening 184 may be spaced from the first and second ends 164, 166 such that the outermost periphery of either of the first and second ends 164, 166 is not interrupted by the third opening 184.

[0035] In some embodiments of the present disclosure, the fluid passageway 170 can further include a fourth opening 188 extending through the outer surface 186 of the insert body. The third and fourth openings 184, 188 are positioned along the outer surface 186 of the insert body relative to the longitudinal axis A1. In some embodiments of the present disclosure, the third and fourth openings 184, 188 are positioned along the outer surface 186 of the insert body such that the third and fourth openings 184, 188 are radially spaced apart about the longitudinal axis A1 of the insert body. For example, the third and fourth openings 184, 188 can be spaced apart by an angle between approximately 10 degrees and approximately 180 degrees relative to the longitudinal axis A1. In some aspects of the present disclosure, the third and fourth openings 184, 188 are spaced apart by an angle of approximately 180 degrees.

[0036] The fluid passageway 170 may further include a fifth opening 190 extending through the outer surface 186 of the inserter body. In such an embodiment, the third and fifth openings 184, 190 may be spaced apart in a direction along the longitudinal axis A1 of the inserter body, with the fourth opening 188 positioned between the third opening 184 and the fifth opening 190.

[0037] The inserter body 106 may be configured with third, fourth, and fifth openings 184, 188, 190 positioned at any radial orientation relative to one another. In some embodiments of the present disclosure, such as the embodiments illustrated in FIGS. 4 and 5A , the third and fifth openings 184, 190 are radially aligned relative to the longitudinal axis A1, and the fourth opening 188 is angularly spaced radially about the longitudinal axis A1. The fourth opening 188 may be angularly spaced from either the third or fifth openings 184, 190 by between approximately 10 degrees and approximately 180 degrees. In some aspects of the present disclosure, the fourth opening 188 is angularly spaced from the third and fifth openings 184, 190 by approximately 180 degrees.

[0038] 4-5B, fluid passageway 170 can include a first portion 172 extending in a first direction D1 away from longitudinal axis A1. A second portion 174 of the fluid passageway extends in a second direction D2 from first portion 172 toward longitudinal axis A1. Second portion 174 of the fluid passageway can extend past longitudinal axis A1, and a third portion of the fluid passageway extends in the first direction D1 from second portion 174 toward longitudinal axis A1.

[0039] In some embodiments of the present disclosure, the fluid passageway 170 includes a fourth portion 178 that extends in a second direction D2 from the third portion 176 toward the longitudinal axis A1. In such embodiments, the second opening 182 of the fluid passageway is fluidly coupled to the fourth portion 178.

[0040] The change in direction of the fluid passageway 170 between the first end 164 and the second end 166 of the insertion body can be determined by the angle between one or more portions of the fluid passageway 170. In some cases, the fluid passageway 170 can have a change in direction by an angle between approximately 45 degrees and approximately 90 degrees. The change in direction of the fluid passageway 170 can form lines representing a periodic wave, such as a square wave. The change in direction of the fluid passageway 170 is optimized to reduce the pressure of the fluid, e.g., blood, moving through the fluid passageway 170 by inducing resistance to the fluid. The risk of hemolysis during blood collection can be advantageously reduced because the reduced blood flow rate results in reduced shear stress experienced by red blood cells in the blood.

[0041] In some embodiments of the present disclosure, the fluid passageway 170 includes eight changes in direction, where each change in direction is approximately 90 degrees. Referring to Figures 5A and 5B, the angles between any of the first, second, third, and fourth portions 172, 174, 176, and 178 and any of the third, fourth, and fifth openings 184, 188, and 190 of the fluid passageway 170 are shown as approximately 90 degrees. Angle AA between the fluid passageway 170 at the first opening 180 and the first portion 172 is approximately 90 degrees, angle AB between the first portion 172 and the fluid passageway 170 along the first opening 180 is approximately 90 degrees, angle AC between the fluid passageway 170 along the third opening 184 and the second portion 174 is approximately 90 degrees, angle AD between the second portion 174 and the fluid passageway 170 along the fourth opening 188 is approximately 90 degrees, The angle AE between the fluid passage 170 along the fourth opening 188 and the third portion 176 is approximately 90 degrees, the angle AF between the third portion 176 and the fluid passage 170 along the fifth opening 190 is approximately 90 degrees, the angle AG between the fluid passage 170 along the fifth opening 190 and the fourth portion 178 is approximately 90 degrees, and the angle AE between the fourth portion 178 and the fluid passage 170 at the second opening 182 is approximately 90 degrees.

[0042] 5B, the movement of fluid through the flow restrictor 100 and along the path of the fluid passage 170 is indicated by arrows. While the arrows indicate movement of fluid through the flow restrictor 100 in a direction from the first end portion 150 to the second end portion 110, it should be understood that the present disclosure contemplates that fluid may move through the flow restrictor 100 in a direction from the second end portion 110 to the first end portion 150.

[0043] When the insert body 106 is positioned within the housing cavity 140, at least a portion of the insert body's outer surface 186 presses against and engages the housing's inner surface that defines the cavity 140. The sections of the fluid passageway 170 at any of the third, fourth, and fifth openings 184, 188, 190 are at least partially defined by the inner surface of the housing 148.

[0044] The housing 148, or a portion thereof, may include a transparent material to allow observation of the fluid within the fluid passageway 170. A housing including a transparent material is shown in Figure 6, although the third opening 184, the fourth opening 188 (not shown), and the fifth opening 190 of the fluid passageway are visible through the exterior surface of the housing.

[0045] In some embodiments, a portion of the housing 148 includes a transparent material forming a window therethrough. The window can be located between the first opening 154 and the second opening 114 of the housing at a location aligned with any of the third, fourth, and fifth openings 184, 188, 190 of the insert body positioned within the housing cavity 140. In some embodiments, the housing 148 includes three windows, each aligned with a respective one of the third, fourth, and fifth openings 184, 188, 190 of the insert body. In yet other embodiments of the present disclosure, the windows can extend around the periphery of the housing such that the third, fourth, and / or fifth openings 184, 188, 190 are longitudinally aligned with the respective windows in any rotational orientation of the insert body relative to the housing.

[0046] In some embodiments of the present disclosure, the insert body 107 can be configured to include a material that is flexible relative to the insert body or other portions of the housing. The flexible material can provide a seal between the insert body and the housing. The insert body 107 can be partially or completely formed of a flexible material, or the insert body 107 can be overmolded with a flexible material. In some aspects of the present disclosure, the flexible material is an elastomer, such as silicone rubber, or a similar material that can provide a fluid seal between the insert body and the housing.

[0047] 7, an insert body 107 formed from a silicone material is shown. The silicone extends along the outer surface of the insert body 107 and can be pressed into engagement with the inner surface of the housing 148 when the insert body 107 is positioned within the housing cavity 140. As shown in FIG. 8, the engagement of the silicone 108 against the inner surface of the housing 148 provides a seal that can prevent fluid from migrating out of the openings of the fluid passageway 170, such as the third, fourth, and fifth openings 184, 188, 190.

[0048] 9, the insert body 109 can include a wall 111 extending away from the outer surface of the insert body. The wall 111 is configured to press against and engage the inner surface of the housing 148 to form a seal when the insert body 109 is positioned within the housing cavity 140, preventing fluid from migrating out of the opening of the fluid passageway 170.

[0049] Walls 111 are positioned to extend around openings of fluid passageway 170, such as third, fourth, and fifth openings 184, 188, 190. Walls 111 can have a height extending away from the outer surface of the insert body and a length extending around the openings of fluid passageway 170. In some embodiments, insert body 109 includes a first wall 111 extending around third opening 184 of the insert body, a second wall 112 extending around fifth opening 190 of the insert body, and a third wall extending around fourth opening of the insert body.

[0050] 10 , when the insert body 109 is positioned within the housing cavity 140, either of the insert body walls 111, 112 can press against and engage the interior surface of the housing 148 to prevent fluid from migrating out of the openings of the fluid passageway 170, such as the third, fourth, and fifth openings 184, 188, 190. In some embodiments of the present disclosure, the walls 111, 112 are compressed or crushed when the insert body 109 is positioned within the housing 148.

[0051] Another aspect of the flow restrictor 100 of the present disclosure is manufacturability optimization for the insert bodies 106, 107, 109. The insert bodies 106, 107, 109 can be manufactured using an efficient molding process in which a core pin is positioned within a mold to form the fluid passageway 170. The core pin can be positioned to form the fluid passageway while allowing for easy removal of the core pin after the insert body is molded, thereby preventing damage to either the fluid passageway or the core pin. In some aspects of the present disclosure, each core pin has two protrusions, each configured to form at least a portion of a fluid passageway 170.

[0052] In FIG. 11 , the core pins are generally shown adjacent to the insert body 106. As shown, first and second core pins C1 and C2 can be positioned within the mold to form the first and second openings 180 and 182, respectively. A third core pin C3 can be positioned between the first and second core pins C1 and C2 within the mold to form the first portion 172, the third opening 184 of the insert body, and the second portion 174 of the fluid passageway. A fourth core pin C4 can be positioned within the mold to form the second portion 174, the fourth opening 188, and the third portion 176 of the fluid passageway. A fifth core pin C5 can be positioned within the mold to form the third portion 176, the fifth opening 190, and the fourth portion 178 of the fourth portion 178.

[0053] 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 aspects of the subject technology are described as numbered clauses (1, 2, 3, etc.) for convenience. These are provided as examples and are not intended to limit the subject technology. Any of the dependent clauses can be combined in any combination and placed into their own independent clauses, e.g., clause 1 or clause 5. Other clauses can be presented in a similar manner.

[0054] Clause 1. A flow restrictor device comprising a housing and an insert body, the housing having a first end portion, a second end portion, an inner surface forming a cavity between the first end portion and the second end portion, a first opening through the first end portion, and a second opening through the second end portion, the insert body having the first end, the second end, a longitudinal axis extending through the first and second ends, and an inner surface forming a fluid passageway extending between the first end and the second end, the fluid passageway having a first portion extending in a first direction away from the longitudinal axis, a second portion extending in a second direction toward the longitudinal axis, and a third portion extending in the first direction, the insert body being positioned within the cavity with the first opening of the fluid passageway fluidly coupled with the first opening of the housing and the second opening of the fluid passageway fluidly coupled with the second opening of the housing.

[0055] Clause 2. The flow restrictor of Clause 1, wherein the fluid passage has a fourth portion extending in a third direction, the third direction being different from the first direction and the second direction.

[0056] Clause 3. The flow restrictor of Clause 2, wherein the third direction is parallel to the longitudinal axis.

[0057] Clause 4. The flow restrictor of Clause 2, wherein the fourth portion is positioned between one of the first portion and the second portion and the second portion and the third portion of the fluid passageway.

[0058] Clause 5. The flow restrictor of Clause 2, wherein at least a portion of any of the first, second, third, and fourth portions of the fluid passageway extends through an outer surface of the insert body.

[0059] Clause 6. The flow restrictor of Clause 2, wherein at least a portion of any of the first, second, third, and fourth portions of the fluid passageway is defined by an inner surface of the housing.

[0060] Clause 7. The flow restrictor of any of clauses 1 to 6, wherein an angle between any of the first, second, and third portions of the fluid passage is between approximately 45 degrees and approximately 180 degrees.

[0061] Clause 8. The flow restrictor of any of clauses 1 to 7, wherein the angle between any of the first, second, and third portions of the fluid passage is approximately 90 degrees.

[0062] Clause 9. The flow restrictor of any of clauses 1 to 8, wherein the fluid passage has a fourth portion extending in the second direction.

[0063] Clause 10. The flow restrictor of Clause 9, wherein an angle between each of the first, second, third, and fourth portions of the fluid passage is approximately 90 degrees.

[0064] Clause 11. The flow restrictor of any of clauses 1 to 10, wherein the first opening of the fluid passageway extends through a first end of the insert body and the second opening of the fluid passageway extends through a second end of the insert body.

[0065] Clause 12. The flow restrictor of any of clauses 1 to 11, wherein at least a portion of the housing comprises a transparent material, and wherein any of the first, second, and third portions of the fluid passageway are forcibly engaged with an inner surface of the housing having the transparent material such that the fluid passageway is visible through the outer surface of the housing.

[0066] Clause 13. The flow restrictor of any of clauses 1 to 12, wherein the housing has a window extending through an outer surface of the housing between the first end portion and the second end portion of the housing, and wherein any of the first, second, and third portions of the fluid passageway are forcibly engaged against an inner surface of the housing at the window such that the fluid passageway is visible through the window.

[0067] Clause 14. The flow restrictor of clause 13, wherein the window is formed by a transparent portion of the housing.

[0068] Clause 15. The flow restrictor of any of clauses 1 to 14, wherein the insert body includes a wall having a height extending away from the outer surface of the insert body and a length extending around a portion of any of the first, second, and third portions of the fluid passageway extending through the outer surface of the insert body.

[0069] Clause 16. The flow restrictor of any of clauses 1 to 15, wherein the outer surface of the insert body comprises a silicone material.

[0070] Clause 17. The flow restrictor of any of clauses 1 to 16, wherein a first end portion of the housing forms either a male luer or a female luer, and a second end portion of the housing forms the other of the male luer or the female luer.

[0071] Clause 18. The flow restrictor of any of clauses 1 to 17, wherein the fluid passage has a cross-sectional area that decreases from the first end of the insert body to the second end of the insert body.

[0072] Clause 19. The flow restrictor of any of clauses 1 to 18, wherein the fluid passage has a cross-sectional area that decreases from the second end of the insert body to the first end of the insert body.

[0073] Clause 20. A flow restrictor device comprising a housing and an insert body, the housing having a first end portion, a second end portion, an inner surface forming a cavity between the first end portion and the second end portion, a first opening through the first end portion, and a second opening through the second end portion, the insert body having a first end, a second end, an outer surface extending between the first end and the second end, and an inner surface forming a fluid passageway extending between the first end and the second end, the fluid passageway having a first opening through the first end of the insert body, a second opening through the second end of the insert body, and a third opening through the outer surface, the insert body being positioned within the cavity with the first opening of the fluid passageway fluidly coupled with the first opening of the housing, the second opening of the fluid passageway fluidly coupled with the second opening of the housing, and the third opening blocked by the inner surface of the housing.

[0074] Clause 21. The flow restrictor of Clause 20, wherein the fluid passage has a fourth opening through the outer surface, the fourth opening spaced apart from the third opening in a direction that is parallel to a longitudinal axis extending through the first and second ends of the insert body.

[0075] Clause 22. The flow restrictor device of any of Clauses 20 and 21, wherein the fluid passage has a fourth opening through the outer surface, the fourth opening spaced apart from the third opening in a radial direction about a longitudinal axis extending through the first and second ends of the insert body.

[0076] Clause 23. The flow restrictor of clause 22, wherein the fourth opening is radially spaced from the third opening by an angle of approximately 180 degrees.

[0077] Clause 24. The flow restrictor of any of clauses 20 to 23, wherein a portion of the fluid passageway along the third opening is formed by an inner surface of the housing.

[0078] Clause 25. The flow restrictor of any of clauses 20 to 24, wherein the fluid passageway has a fourth opening through the outer surface and a fifth opening through the outer surface, any of the third, fourth, and fifth openings being spaced apart from one another relative to a longitudinal axis extending through the first and second ends of the insert body.

[0079] Clause 26. The flow restrictor of any of clauses 20 to 25, wherein the housing has a window extending through an exterior surface of the housing between the first end portion and the second end portion of the housing, and the third opening of the fluid passage is aligned with the window such that the fluid passage is visible through the window.

[0080] Clause 27. The flow restrictor of clause 26, wherein the window is formed by a transparent portion of the housing.

[0081] Clause 28. The flow restrictor of Clause 26, wherein the insert body includes a wall having a height extending away from the outer surface of the housing and a length extending around the third opening through the outer surface.

[0082] Clause 29. The flow restrictor of any of clauses 20 to 28, wherein the outer surface of the insert body comprises a silicone material.

[0083] Clause 30. The flow restrictor of any of clauses 20 to 29, wherein a first end portion of the housing forms either a male luer or a female luer, and a second end portion of the housing forms the other of the male luer or the female luer.

[0084] Clause 31. A peripheral intravenous catheter assembly configured to limit hemolysis during blood withdrawal from a patient, comprising: a flow restrictor; a catheter hub; and a fluid connector, wherein the flow restrictor has a housing and an insertion body, the housing having a first end portion, a second end portion, an inner surface forming a cavity between the first end portion and the second end portion, and a first opening through the first end portion, the first end portion configured to be coupled to the catheter assembly, and the second end portion configured to be coupled to a fluid collection device, the insertion body having a first end, a second end, a longitudinal axis extending through the first and second ends, and a fluid passageway extending between the first end and the second end. a fluid passageway having a first portion extending in a first direction away from the longitudinal axis, a second portion extending in a second direction toward the longitudinal axis, and a third portion extending in the first direction; an insertion body positioned within the cavity from the first end portion of the housing through the second end portion of the housing with the first opening of the fluid passageway fluidly coupled with the first opening of the housing and the second opening of the fluid passageway fluidly coupled with the second opening of the housing to limit hemolysis of blood drawn from a patient into a fluid collection device; a catheter hub having a proximal end and a distal end; and a fluid connector fluidly coupling the catheter hub to the flow restriction device.

[0085] This disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. While this disclosure provides various examples of the subject technology, 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.

[0086] Reference to an element in the singular is not intended to mean "one and only one" unless specifically so stated, but rather "one or more." The term "some" refers to one or more unless specifically stated otherwise. Pronouns referring to the masculine (e.g., his) include the 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.

[0087] 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.

[0088] 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 word "or" used to separate 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 A only, B only, or C only, or any combination of A, B, and C.

[0089] The use of a phrase such as "aspect" does not imply that such aspect is essential to the subject technology or that such aspect applies to all configurations of the subject technology. Disclosure 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 "aspect" may refer to one or more aspects, and vice versa. A phrase such as "embodiment" does not imply that such an embodiment is essential to the subject technology or that such an embodiment applies to all configurations of the subject technology. Disclosure 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 "embodiment" may refer to one or more examples, and vice versa. A phrase such as "configuration" does not imply that such a configuration is essential to the subject technology or that such a configuration applies to all configurations of the subject technology. 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.

[0090] In one aspect, unless otherwise stated, all measurements, values, ratings, locations, dimensions, sizes, and other specifications set forth herein, including those contained in the claims that follow, are approximate and not precise, and are intended to have a reasonable range consistent with the functions to which they relate and with what is customary in the technical field to which they pertain.

[0091] 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 operations in a sample order, and are not meant to be limited to the specific order or hierarchy presented.

[0092] 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 expressly recited in the claims. No element of a claim is to be construed under the provisions of 35 U.S.C. § 112(f) unless the element is expressly recited using the phrase "means for," or, in the case of a method claim, 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 "comprises" is interpreted when used as a transitional word in a claim.

[0093] The title, background art, summary, brief description of the drawings, and abstract of this disclosure are hereby incorporated into this disclosure and are provided as illustrative examples of the disclosure, not as a limiting description. This disclosure is submitted with the understanding that they are not used to limit the scope or meaning of the claims. Furthermore, in the Detailed Description, it is understood that the description provides illustrative examples, and that various features have been grouped together in various embodiments to streamline the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that 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.

[0094] 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 encompass all legal equivalents. However, none of the claims are intended, and should not be construed, to cover subject matter that does not satisfy the requirements of 35 U.S.C. §§ 101, 102, or 103.

Claims

1. a housing having a first end portion, a second end portion, an interior surface forming a cavity between the first end portion and the second end portion, a first opening extending through the first end portion to the cavity, and a second opening extending through the second end portion to the cavity; 1. A flow restricting device comprising: an insert body having a first end, a second end, a longitudinal axis extending through the first end and the second end, and an interior surface defining a fluid passageway extending between the first end and the second end, the fluid passageway having a first portion extending in a first direction away from the longitudinal axis, a second portion extending in a second direction toward the longitudinal axis, and a third portion extending in the first direction; a fluid passageway extending through an outer surface of the insert body and located between the first end and the second end of the insert body; a fluid passageway extending through an outer surface of the insert body and located between the first end and the second end of the insert body; a fluid passageway extending through an outer surface of the insert body and located between the first end and the second end of the insert body; a fluid passageway extending through an outer surface of the insert body and located between the first end and the second end of the insert body;

2. 2. The flow restricting device of claim 1, wherein the fluid passageway along the third opening extends in a third direction, the third direction being different from the first direction and the second direction.

3. The flow restricting device of claim 2 , wherein the third direction is parallel to the longitudinal axis.

4. The flow restricting device of claim 1 , wherein the fourth opening is positioned between one of the first and second portions of the fluid passage and the second and third portions of the fluid passage.

5. The flow restricting device of claim 1 , wherein at least a portion of the fluid passage is defined by the interior surface of the housing.

6. 2. The flow restricting device of claim 1, wherein an angle between any of the first, second, and third portions of the fluid passage is between 45 and 180 degrees.

7. 2. The flow restricting device of claim 1, wherein an angle between any of the first portion, the second portion, and the third portion of the fluid passage is 90 degrees.

8. The flow restricting device of claim 1 , wherein the fluid passage has a fourth portion extending in the second direction.

9. 2. The flow restricting device of claim 1, wherein at least a portion of the housing comprises a transparent material, and either the third opening or the fourth opening of the fluid passage is pressed against the inner surface of the housing having the transparent material so that the fluid passage is visible through the outer surface of the housing.

10. 2. The flow restricting device of claim 1, wherein the insert body includes a wall having a height extending away from an outer surface of the insert body and a length extending around a portion of either the third opening or the fourth opening of the fluid passage extending through the outer surface of the insert body.

11. The flow restrictor device of claim 1 , wherein the fluid passage has a cross-sectional area that decreases from the first end of the insert body to the second end of the insert body.

12. The flow restricting device of claim 1 , wherein the fluid passage has a cross-sectional area that decreases from the second end of the insert body to the first end of the insert body.

13. The flow restricting device of claim 1 , wherein either the third opening or the fourth opening of the fluid passageway is spaced apart from the first end and the second end of the insertion body.

14. a housing having a first end portion, a second end portion, an interior surface forming a cavity between the first end portion and the second end portion, a first opening extending through the first end portion to the cavity, and a second opening extending through the second end portion to the cavity; 1. A flow restricting device comprising: an insert body having a first end, a second end, an outer surface extending between the first end and the second end, and an inner surface defining a fluid passageway extending between the first end and the second end, the fluid passageway including a first opening through the first end of the insert body, a second opening through the second end of the insert body, a third opening through the outer surface, and a fourth opening through the outer surface, the fourth opening being spaced apart from the third opening; the insertion body is positioned within the cavity with the first opening of the fluid passage fluidly coupled with the first opening of the housing, the second opening of the fluid passage fluidly coupled with the second opening of the housing, and the third opening blocked by the inner surface of the housing.

15. 15. The flow restricting device of claim 14, wherein the fourth opening is spaced apart from the third opening in a direction parallel to a longitudinal axis extending through the first and second ends of the insertion body.

16. 15. The flow restricting device of claim 14, wherein the fourth opening is spaced radially from the third opening about a longitudinal axis extending through the first end and the second end of the insert body.

17. 15. The flow restricting device of claim 14, wherein a portion of the fluid passageway along either the third opening or the fourth opening is defined by the inner surface of the housing.

18. 15. The flow restricting device of claim 14, wherein the fluid passage has a fifth opening through the outer surface, and any of the third opening, the fourth opening, and the fifth opening are spaced apart relative to a longitudinal axis extending through the first end and the second end of the insertion body.

19. 15. The flow restricting device of claim 14, wherein the housing has a window extending through an outer surface of the housing between the first end portion and the second end portion of the housing, and either the third opening or the fourth opening of the fluid passage is aligned with the window so that the fluid passage is visible through the window.

20. 20. The flow restricting device of claim 19, wherein the insert body includes a wall having a height extending away from an outer surface of the housing and a length extending around either the third opening or the fourth opening through the outer surface.

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