Hemolysis reduction accessory for direct blood sampling

Abstract

The flow restriction device can include a housing having first and second end portions forming respective first and second openings, and a cavity configured to receive an insertion body defining a fluid passage extending from a first opening of the housing at the first end portion to a second opening of the housing at the second end portion, wherein the fluid passage extends in more than one direction along a path between the first and second end portions of the housing to induce resistance to fluid flow moving through the device, thereby reducing the flow rate and pressure of the fluid, which is blood, and reducing the hemolytic index of the blood.

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 hereby incorporated by reference in its entirety.

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

Background Art

[0003] Catheters are generally used for various infusion therapies. For example, a catheter can be used to infuse fluids such as saline, various drugs, and total parenteral nutrition into a patient. A catheter can also be used to withdraw blood from a patient.

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

[0005] To verify proper placement of the guide needle and / or catheter within a blood vessel, a clinician generally checks for a "flashback" of blood within the flashback chamber of the catheter assembly. Once the needle placement is confirmed, the clinician can temporarily occlude the flow within the vasculature, remove the needle, and leave the catheter in place for future blood sampling or fluid infusion.

[0006] For blood collection from a patient, or for collecting a blood sample from a patient, a blood collection container may be used. The blood collection container can include a syringe. Alternatively, the blood collection container may include a test tube having 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, such that the pressure within the test tube is lower 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] The blood collection container may be coupled to the catheter. When the blood collection container is coupled to the catheter, the pressure within the vein is higher than the pressure within the blood collection container. As a result, blood is pushed into the blood collection container, and thus the blood collection container becomes filled with blood. The degree of vacuum within the blood collection container decreases as the blood collection container is filled, and the pressure within the blood collection container becomes equal to the pressure within the vein, ultimately stopping the flow of blood.

[0008] Unfortunately, when blood is drawn into the blood collection container, due to the high initial pressure differential between the vein and the blood collection container, red blood cells are placed in a high shear stress state and are prone to hemolysis. Hemolysis can lead to rejection and discard of the blood sample. The high initial pressure differential can further lead to catheter tip collapse, vein collapse, or other problems that impede or limit filling of the blood collection container with blood. Additionally, generally, blood spillage occurs during and / or after blood collection.

[0009] The description given in the Background Art section should not be regarded as prior art merely because it is stated in, or merely associated with, the Background Art section. The Background Art section can include information that explains one or more aspects of the subject technology.

Summary of the Invention

Means for Solving the Problems

[0010] The present disclosure provides a flow rate limiting device, which includes a housing and an insertion body. The housing has a first end portion, a second end portion, an inner surface that forms a cavity between the first end portion and the second end portion, a first opening penetrating the first end portion, and a second opening penetrating the second end portion. The insertion body has a first end, a second end, a longitudinal axis extending through the first and second ends, and an inner surface that forms a fluid passage extending between the first end and the second end. 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. The insertion body is positioned within the cavity with the first opening of the fluid passage fluidly coupled to the first opening of the housing and the second opening of the fluid passage fluidly coupled to the second opening of the housing.

[0011] In some cases, the present disclosure provides a flow restriction device, the flow restriction device comprising 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, a first opening passing through the first end portion, and a second opening passing through the second end portion, the insertion 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 passing through the first end of the insertion body, a second opening passing through the second end of the insertion body, and a third opening passing through the outer surface, the insertion body being positioned within the cavity with the first opening of the fluid passage in fluid communication with the first opening of the housing, the second opening of the fluid passage in fluid communication with 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 includes a flow restriction device, a catheter hub, and a fluid connector. The flow restriction device has a housing and an insertion body. The housing has a first end portion, a second end portion, an inner surface that forms a cavity between the first end portion and the second end portion, and a first opening that penetrates the first end portion. The first end portion is configured to be coupled to the catheter assembly, and the second end portion is configured to be coupled to a fluid collection device. The insertion body has a first end, a second end, a longitudinal axis extending through the first and second ends, and an inner surface that forms a fluid passage extending between the first end and the second end. 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. The insertion body is positioned within the cavity such that a first opening of the fluid passage is fluidly coupled to the first opening of the housing and a second opening of the fluid passage is fluidly coupled to the second opening of the housing, in order to limit hemolysis of blood collected from the patient through the fluid collection device via the second end portion of the housing from the first end portion of the housing. The catheter hub has a proximal end and a distal end, and the fluid connector fluidly couples the catheter hub to the flow restriction device.

[0013] It will be understood that other configurations of the subject technology will be readily apparent to those skilled in the art from the following detailed description, and various configurations of the subject technology are illustrated and described. As will be understood, the subject technology is capable of other and different configurations, and some of its details are capable of modification in various other respects 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 restrictive.

[0014] The following drawings are included to illustrate certain aspects of the embodiments and should not be regarded as exclusive embodiments. The disclosed subject matter is capable of considerable modification, alteration, combination, and equivalents in forms and functions that will occur to those skilled in the art and that will enjoy the benefits of this disclosure.

Brief Description of the Drawings

[0015]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5A

Figure 5B

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Figure 7

Figure 8

Figure 9

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Figure 11

Best Mode for Carrying Out the Invention

[0016] The detailed description set forth below describes various configurations of the subject technology and is not intended to represent only those configurations in which the subject technology may be practiced. The detailed description includes specific details for achieving a complete understanding of the subject technology. Accordingly, dimensions may be given as non-limiting examples with respect to certain aspects. 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 this disclosure includes examples of the subject technology and is not intended to limit the scope of the appended claims. Next, various aspects of the subject technology will be disclosed by way of non-limiting but specific examples. The various embodiments described in this disclosure may be implemented in different manners and variations and may be executed according to the desired use or implementation.

[0018] Blood collection via a vascular access device is attracting increasing attention due to minimal needle pricks and improved working efficiency compared to the conventional blood collection method by venipuncture. Current blood collection using a peripheral intravenous catheter (PIVC) encounters several problems, one of the most significant being the quality of the blood related to hemolysis. In particular, with standard connections (such as short extension sets and needleless connectors) and currently existing PIVC products on the market, as well as blood collection devices (such as vacutainers), the shear stress acting on blood cells tends to be on the verge of causing hemolysis.

[0019] Various embodiments of the present disclosure are directed to providing systems and methods for addressing hemolysis in PIVC blood sampling using a hemolysis reduction accessory (also referred to herein as a flow restriction device), the hemolysis reduction accessory being capable of being pre-attached to a PIVC and reducing flow rate to reduce the risk of hemolysis. The hemolysis reduction accessory is advantageously adapted to PIVC placement and requires no change to any of the current procedures. The hemolysis reduction accessories of the 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 rate reduction using an add-on hemolysis reduction accessory (also referred to herein as a flow restriction device), the hemolysis reduction accessory regulating the overall flow rate of the entire fluid path through which blood cells travel. The flow restriction device may be assembled with the PIVC or co-packaged with the PIVC. Thus, the device can allow for blood flashback, so there are no further procedures during catheter placement. The clinician can place the blood collection device at the accessory port or opening and then draw blood into the desired volume. After blood sampling, the clinician can disconnect and discard the flow restriction device and the blood collection device together. Thus, this flow restriction device can be used for a single blood sampling or can remain in-line throughout the indwelling.

[0021] The flow rate limiting devices and related blood collection systems of the various embodiments described herein provide additional advantages over currently existing blood collection systems. For example, the add-on flow rate limiting device described herein enables integration of a hemolysis reduction function for PIVC blood collection. Further, the flow rate limiting device described herein is adapted for PIVC placement and enables seamless blood collection upon insertion. Further, since the flow rate limiting device is add-on, it can be easily incorporated without any modification to an existing PIVC, with minimal impact on the clinical environment and procedures.

[0022] FIG. 1 shows a vascular access device 10 including a peripheral intravenous catheter (PIVC) assembly 50 including a flow rate limiting device 100, according to some embodiments of the present disclosure. The flow rate limiting device 100 may 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 may include a catheter assembly 50. The catheter assembly 50 may include a catheter hub 52 that may include a distal end 54, a proximal end 56, and a lumen extending through the distal and proximal ends. The catheter assembly 50 may be fixed within the catheter hub 52 and may further include a catheter 58 extending distally from the distal end 54 of the catheter hub 52. In some embodiments, the catheter assembly 50 may be a peripheral intravenous catheter (PIVC).

[0023] In some embodiments, the catheter assembly 50 may include any suitable catheter assembly 50 or may correspond to any suitable catheter assembly 50. In some embodiments, the catheter assembly 50 may be integrated and may include an extension tube 60 that extends from and may be 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 restriction device 100 may be fluidly coupled to the Y-adapter 70.

[0024] In some embodiments, the catheter assembly 50 may be in a non-integrated form and may not include an extension tube 60. In these and other embodiments, the flow restriction device 100 may be configured to be coupled to the proximal end 56 of the catheter hub 52 or to another suitable portion of the catheter assembly 50. In some embodiments, the flow restriction device 100 may be directly coupled to the catheter assembly 50, thereby eliminating the extension tube 60 and providing a compact catheter system.

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

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

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

[0028] The first end portion 150 can have an inner surface 156 that forms a first opening 154. The second end portion 110 can include an inner surface 115 that forms a second opening 114 that extends therethrough for coupling to the male Luer portion of the blood collection device 40. The second opening 114 of the second end portion can be fluidly connected to the first opening 154 of the first end portion via a cavity 140 formed by the inner 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 that extends therethrough, and the second end portion 110 of the housing can be formed as the other of the male and / or female Luer connectors having a second opening 114 that extends therethrough. The housing 148 can include 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 integral 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 through the cavity 140 to the second opening of the second end portion.

[0031] The cavity 140 is configured to receive the insertion body 106 therein. The insertion body 106 guides the 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 flow moves through the insertion body 106. By inducing resistance to the fluid flow, the velocity of the fluid flow is reduced as the fluid moves through the insertion body 106. By reducing the flow rate of a fluid such as blood through the flow rate limiting device 100, the hemolysis index of the blood can be reduced.

[0032] The insertion body 106 has a first end 164, a second end 166, and an inner surface 168 that forms a fluid passage 170 extending through the first and second ends 164, 166. The fluid passage 170 extends along a path between the first end 164 and the second end 166 of the body and is configured to reduce the velocity of the fluid flow passing through the insertion body 106. A perspective view of the insertion body 106 is shown in FIG. 4, and by showing the body transparently, the fluid passage 170 can be visualized in connection with the present disclosure.

[0033] In some embodiments of the present disclosure, the first end 164 of the insertion body and the second end 166 of the insertion body respectively form the nearest surface and the farthest surface of the body. The insertion body 106 can further define a longitudinal axis A1 extending through the first and second ends 164, 166. The fluid passage 170 spans between the first end 164 and the second end 166 of the insertion body and is configured to extend in more than two directions along the path between the first end 164 and the second end 166. Since the path extends in more than two directions, the fluid passage 170 extends indirectly between the first end 164 and the second end 166 of the insertion body. The indirect path between the first end 164 and the second end 166 of the body can have a length greater than the distance between the first end 164 and the second end 166 of the body.

[0034] The fluid passage 170 includes a first opening 180 passing through the first end 164 of the insertion body and a second opening 182 passing through the second end 166 of the insertion body. Between the first opening 180 and the second opening 182, the fluid passage 170 can include a third opening 184 passing through the outer surface 186 of the insertion 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 can 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 passage 170 can further include a fourth opening 188 that penetrates the outer surface 186 of the insertion body. The third and fourth openings 184, 188 are positioned along the outer surface 186 of the insertion body relative to the longitudinal axis A1. In some embodiments of the present disclosure, the third and fourth openings 184, 188 are arranged along the outer surface 186 of the insertion body such that the third and fourth openings 184, 188 are radially spaced around the longitudinal axis A1 of the insertion 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 passage 170 can further include a fifth opening 190 that penetrates the outer surface 186 of the insertion body. In such embodiments, the third and fifth openings 184, 190 can be spaced apart in a direction along the longitudinal axis A1 of the insertion body with the fourth opening 188 positioned between the third opening 184 and the fifth opening 190.

[0037] The insertion body 106 can be configured by the third, fourth, and fifth openings 184, 188, 190 positioned in any radial orientation relative to each other. 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 radially spaced at an angle around the longitudinal axis A1. The fourth opening 188 can be spaced apart from either of the third and fifth openings 184, 190 by an angle between approximately 10 degrees and approximately 180 degrees. In some aspects of the present disclosure, the fourth opening 188 is spaced apart from the third and fifth openings 184, 190 by an angle of approximately 180 degrees.

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

[0039] In some embodiments of the present disclosure, the fluid passageway 170 includes a fourth portion 178 that extends in the 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 in fluid communication with 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 set 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 a line representing a periodic wave, such as a square wave. The change in direction of the fluid passageway is optimized to reduce the pressure of the fluid, such as blood, moving through the fluid passageway 170 by inducing resistance to the fluid. The reduced blood flow rate results in a reduction in the shear stress experienced by the red blood cells of the blood, so the risk of hemolysis during blood collection can be advantageously reduced.

[0041] In some embodiments of the present disclosure, the fluid passage 170 includes eight changes in direction, where each change in direction is approximately 90 degrees. Referring to FIGS. 5A and 5B, the angle between any one of the first, second, third, and fourth portions 172, 174, 176, 178 and any one of the third, fourth, and fifth openings 184, 188, 190 of the fluid passage 170 is shown as approximately 90 degrees. The angle AA between the fluid passage 170 and the first portion 172 at the first opening 180 is approximately 90 degrees, the angle AB between the first portion 172 and the fluid passage 170 along the first opening 180 is approximately 90 degrees, the angle AC between the fluid passage 170 along the third opening 184 and the second portion 174 is approximately 90 degrees, the angle AD between the second portion 174 and the fluid passage 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] Referring to FIG. 5B, the movement of fluid through the flow restrictor 100 and along the path of the fluid passage 170 is indicated by the arrows. The arrows indicate the movement of fluid through the flow restrictor 100 from the first end portion 150 in the direction of the second end portion 110, but it should be understood that the present disclosure contemplates that fluid can move through the flow restrictor 100 in the direction from the second end portion 110 to the first end portion 150.

[0043] When the insertion body 106 is positioned within the cavity 140 of the housing, at least a portion of the outer surface 186 of the insertion body is pressed against and engaged with the inner surface of the housing forming the cavity 140. The section of the fluid passage 170 at any one of the third, fourth, and fifth openings 184, 188, 190 is at least partially formed by the inner surface of the housing 148.

[0044] The housing 148, or a portion thereof, can include a transparent material so that the fluid within the fluid passage 170 can be observed. The housing including the transparent material is shown in FIG. 6, provided that the third opening 184, the fourth opening 188 (not shown), and the fifth opening 190 of the fluid passage are visible through the outer surface of the housing.

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

[0046] In some embodiments of the present disclosure, the insertion body 107 can be configured to include a material that is flexible relative to the insertion body or other portions of the housing. The flexible material can provide a seal between the insertion body and the housing. The insertion body 107 can be partially or completely formed of the flexible material, or the insertion body 107 can be overmolded with the 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 insertion body and the housing.

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

[0048] In some embodiments of the present disclosure, as shown in FIG. 9, the insertion body 109 can include a wall 111 that extends in a direction away from the outer surface of the insertion body. The wall 111 is configured to be pressed against and engaged with the inner surface of the housing 148 to provide a seal when the insertion body 109 is positioned within the cavity 140 of the housing, and the seal prevents fluid from moving out of the openings of the fluid passage 170.

[0049] The wall 111 is positioned to extend around the openings of the fluid passage 170 such as the third, fourth, and fifth openings 184, 188, 190. The wall 111 can have a height that extends in a direction away from the outer surface of the insertion body and a length that extends around the openings of the fluid passage 170. In some aspects, the insertion body 109 includes a first wall 111 that extends around the third opening 184 of the insertion body, a second wall 112 that extends around the fifth opening 190 of the insertion body, and a third wall that extends around the fourth opening of the insertion body.

[0050] As shown in FIG. 10, when the insertion body 109 is positioned within the cavity 140 of the housing, either of the walls 111, 112 of the insertion body can be pressed against and engaged with the inner surface of the housing 148 to prevent fluid from moving out of the openings of the fluid passage 170 such as the third, fourth, and fifth openings 184, 188, 190. In some embodiments of the present disclosure, when the insertion body 109 is positioned within the housing 148, the walls 111, 112 are compressed or crushed.

[0051] Another aspect of the flow rate limiting device 100 of the present disclosure is the optimization of manufacturability for the insertion bodies 106, 107, 109. The insertion bodies 106, 107, 109 can be manufactured using an efficient molding process in which the core pins are positioned in the mold to form the fluid passage 170. While the core pins can be arranged to form the fluid passage, after the insertion body is molded, the core pins can be easily removed, thereby preventing damage to both the fluid passage and the core pins. In some aspects of the present disclosure, each core pin has two protrusions, where each protrusion is configured to form at least a portion of the fluid passage 170.

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

[0053] Description as a technical clause of the subject The subject technology is described, for example, according to various aspects described 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 do not limit the subject technology. Any combination of the dependent clauses can be combined and incorporated into each independent clause, for example, clause 1 or clause 5. Other clauses can be presented in a similar manner.

[0054] Clause 1. A flow rate limiting device comprising a housing and an insertion body, wherein the housing has 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 penetrating the first end portion, and a second opening penetrating the second end portion, and the insertion body has 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, and the insertion body is positioned within the cavity with the first opening of the fluid passage fluidly coupled to the first opening of the housing and the second opening of the fluid passage fluidly coupled to the second opening of the housing.

[0055] Clause 2. The flow rate limiting device 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 rate limiting device of Clause 2, wherein the third direction is parallel to the longitudinal axis.

[0057] Clause 4. The flow rate limiting device of Clause 2, wherein the fourth portion is positioned between either the first portion or the second portion of the fluid passage and the second portion and the third portion.

[0058] Clause 5. The flow rate limiting device of Clause 2, wherein at least a portion of any one of the first, second, third, and fourth portions of the fluid passage extends through the outer surface of the insertion body.

[0059] Clause 6. The flow rate limiting device of Clause 2, wherein at least a portion of any one of the first, second, third, and fourth portions of the fluid passage is formed by the inner surface of the housing.

[0060] Clause 7. The flow rate limiting device according to any one of Clauses 1 to 6, wherein the 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. A flow rate limiting device according to any one 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. A flow rate limiting device according to any one of Clauses 1 to 8, wherein the fluid passage has a fourth portion extending in a second direction.

[0063] Clause 10. A flow rate limiting device according to Clause 9, wherein the angle between each of the first, second, third, and fourth portions of the fluid passage is approximately 90 degrees.

[0064] Clause 11. A flow rate limiting device according to any one of Clauses 1 to 10, wherein the first opening of the fluid passage extends through the first end of the insertion body, and the second opening of the fluid passage extends through the second end of the insertion body.

[0065] Clause 12. A flow rate limiting device according to any one of Clauses 1 to 11, wherein at least a portion of the housing includes a transparent material, and any of the first, second, and third portions of the fluid passage is engaged by being 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.

[0066] Clause 13. A flow rate limiting device according to any one of Clauses 1 to 12, wherein the housing has a window extending through the outer surface of the housing between the first end portion and the second end portion of the housing, and any of the first, second, and third portions of the fluid passage is engaged by being pressed against the inner surface of the housing by the window so that the fluid passage is visible through the window.

[0067] Clause 14. A flow rate limiting device according to Clause 13, wherein the window is formed by a transparent portion of the housing.

[0068] Clause 15. A flow rate limiting device according to any one of Clauses 1 to 14, wherein the insertion body includes a wall having a height extending in a direction away from the outer surface of the insertion body and a length extending around a portion of any of the first, second, and third portions of the fluid passage extending through the outer surface of the insertion body.

[0069] Clause 16. A flow rate limiting device according to any one of Clauses 1 to 15, wherein the outer surface of the insertion body contains a silicone material.

[0070] Clause 17. A flow rate limiting device according to any one of Clauses 1 to 16, wherein the first end portion of the housing forms either a male Luer or a female Luer, and the second end portion of the housing forms the other of the male Luer or the female Luer.

[0071] Clause 18. A flow rate limiting device according to any one of Clauses 1 to 17, wherein the fluid passage has a cross-sectional area that decreases from the first end of the insertion body toward the second end of the insertion body.

[0072] Clause 19. A flow rate limiting device according to any one of Clauses 1 to 18, wherein the fluid passage has a cross-sectional area that decreases from the second end of the insertion body toward the first end of the insertion body.

[0073] Clause 20. A flow rate limiting device comprising a housing and an insertion body, wherein the housing has a first end portion, a second end portion, an inner surface that forms a cavity between the first end portion and the second end portion, a first opening that penetrates the first end portion, and a second opening that penetrates the second end portion; the insertion body has a first end, a second end, an outer surface that extends between the first end and the second end, and an inner surface that forms a fluid passage extending between the first end and the second end; the fluid passage has a first opening that penetrates the first end of the insertion body, a second opening that penetrates the second end of the insertion body, and a third opening that penetrates the outer surface; the insertion body is 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.

[0074] Clause 21. A flow rate limiting device according to Clause 20, wherein the fluid passage has a fourth opening that penetrates the outer surface, and the fourth opening is spaced from the third opening in a direction parallel to the longitudinal axis that extends through the first and second ends of the insertion body.

[0075] Clause 22. The fluid passage has a fourth opening that penetrates the outer surface, and the fourth opening is radially spaced from the third opening around the longitudinal axis that extends through the first and second ends of the insertion body, for the flow rate limiting device of either of Clauses 20 and 21.

[0076] Clause 23. The fourth opening is radially spaced from the third opening by an angle of approximately 180 degrees, for the flow rate limiting device of Clause 22.

[0077] Clause 24. The portion along the third opening of the fluid passage is formed by the inner surface of the housing, for the flow rate limiting device of any of Clauses 20 to 23.

[0078] Clause 25. The fluid passage has a fourth opening that penetrates the outer surface and a fifth opening that penetrates the outer surface, and any of the third, fourth, and fifth openings are spaced apart from each other relative to the longitudinal axis that extends through the first and second ends of the insertion body, for the flow rate limiting device of any of Clauses 20 to 24.

[0079] Clause 26. The housing has a window that extends through the outer 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 so that the fluid passage is visible through the window, for the flow rate limiting device of any of Clauses 20 to 25.

[0080] Clause 27. The window is formed by a transparent portion of the housing, for the flow rate limiting device of Clause 26.

[0081] Clause 28. The insertion body includes a wall having a height that extends in a direction away from the outer surface of the housing and a length that extends around the third opening that penetrates the outer surface, for the flow rate limiting device of Clause 26.

[0082] Clause 29. The outer surface of the insertion body includes a silicone material, for the flow rate limiting device of any of Clauses 20 to 28.

[0083] Clause 30. A flow restrictor according to any of Clauses 20 to 29, wherein the first end portion of the housing forms either a male luer or a female luer, and the 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 collection from a patient, comprising 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 inner surface forming a cavity between the first end portion and the second end portion, and a first opening passing through the first end portion, the first end portion being configured to be coupled to the catheter assembly, the second end portion being 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 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 insertion body being positioned within the cavity such that a first opening of the fluid passage is fluidly coupled to the first opening of the housing and a second opening of the fluid passage is fluidly coupled to the second opening of the housing, in order to limit hemolysis of blood collected from the patient through the fluid collection device, via the second end portion of the housing, from the first end portion of the housing, the catheter hub having a proximal end and a distal end, and the fluid connector fluidly coupling the catheter hub to the flow restrictor.

[0085] This disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. The 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 general principles defined herein can be applied to other aspects.

[0086] References to an element in the singular are intended to mean "one or more" rather than "only one" unless specifically stated otherwise. Unless specifically stated otherwise, the term "some" refers to one or more. Pronouns referring to a male (e.g., his) include those referring to a female and a neuter (e.g., her and its), and vice versa. Titles and subtitles, if any, are used for convenience only and do not limit the invention.

[0087] As used herein, the word "exemplary" is used to mean "serving as an example or illustration". Any aspect or design described herein as "exemplary" should not necessarily be construed as more preferred or advantageous than 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 series of items modifies the list as a whole rather than each item in the list by using the term "or" 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 this 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. By way of example, 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.

[0089] Phrases such as "aspect" do not imply that such an aspect is essential to the technology of the subject matter, nor that such an aspect applies to all configurations of the technology of the subject matter. The disclosure regarding an aspect may apply to all configurations, or one or more configurations. An aspect can provide one or more examples. Phrases such as "aspect" can refer to one or more aspects, and vice versa. Phrases such as "example" do not imply that such an example is essential to the technology of the subject matter, nor that such an example applies to all configurations of the technology of the subject matter. The disclosure regarding an example may apply to all examples, or one or more examples. An example can provide one or more examples. Phrases such as "example" can refer to one or more examples, and vice versa. Phrases such as "configuration" do not imply that such a configuration is essential to the technology of the subject matter, nor that such a configuration applies to all configurations of the technology of the subject matter. The disclosure regarding a configuration may apply to all configurations, or one or more configurations. A configuration can provide one or more examples. Phrases such as "configuration" can refer to one or more configurations, and vice versa.

[0090] In one aspect, unless stated otherwise, all measurements, values, ratings, positions, sizes, dimensions, and other specifications set forth in this specification, including those included in the following claims, are approximate and not exact. In one aspect, they are intended to have a reasonable range consistent with the functions to which they pertain and what is conventional in the technical fields to which they relate.

[0091] The specific order or hierarchy of steps or operations in the disclosed processes or methods is understood to be illustrative of exemplary approaches. It is understood that the specific order or hierarchy of steps, operations, or processes may be rearranged based on implementation priorities or scenarios. Some of the steps, operations, or processes may be performed simultaneously. In some implementation priorities or scenarios, a particular operation may or may not be performed. Some or all of the steps, operations, or processes may be automatically performed without user intervention. The appended method claims present the 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.

[0092] All structural and functional equivalents to the elements of the various aspects described throughout this disclosure, known or later to become known to those of ordinary skill in the art, are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is expressly recited in the claims. No claim element is to be construed under the provisions of 35 U.S.C. § 112, paragraph (f), unless the element is expressly recited using the phrase "means for" or, in the case of a method claim, the element is expressly recited using the phrase "step for." Further, to the extent the terms "comprising," "having," etc. are used, such terms are intended to be inclusive in a manner similar to the term "comprising" as interpreted when utilized as a transitional word in a claim.

[0093] The title, background art, summary of the invention, brief description of the drawings, and abstract of the present disclosure are incorporated herein by reference and provided as illustrative examples of the present disclosure, not as a limiting recitation. The present disclosure is submitted with the understanding that it is not to be used to limit what the claims scope or mean. Further, in the detailed description of the invention, it can be understood that the description provides illustrative examples and that various features are grouped together in various embodiments in order to streamline the present disclosure. This method of disclosure should not be construed as indicating an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as the following claims show, the subject matter of the invention lies in less than all of the features of a single disclosed configuration or operation. The following claims are hereby incorporated into the detailed description of the invention, and each claim stands on its own as a separately claimed subject matter.

[0094] The claims are not intended to be limited to the aspects described herein, but rather should be given the full scope consistent with the language of the claims and should include all legal equivalents. However, none of the claims is intended to cover, nor should be construed to cover, subject matter that fails to meet 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 inner surface forming a cavity between the first end portion and the second end portion, a first opening penetrating the first end portion to the cavity, and a second opening penetrating the second end portion to the cavity, An insertion body having a first end, a second end, a longitudinal axis extending through 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 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 insertion body is positioned within the cavity in a state where a first opening of the fluid passage is fluidly coupled to the first opening of the housing, a second opening of the fluid passage is fluidly coupled to the second opening of the housing, a third opening of the fluid passage extends through the outer surface of the insertion body and is located at a location between the first end and the second end of the insertion body, and a fourth opening of the fluid passage extends through the outer surface of the insertion body and is located at a location between the first end and the second end of the insertion body, and the fourth opening is spaced apart from the third opening.

2. The flow rate limiting device according to claim 1, wherein the fluid passage along the third opening extends in a third direction, and the third direction is different from the first direction and the second direction.

3. The flow rate limiting device according to claim 2, wherein the third direction is parallel to the longitudinal axis.

4. The flow rate limiting device according to claim 1, wherein the fourth opening is positioned between either the first portion and the second portion of the fluid passage and the second portion and the third portion of the fluid passage.

5. The flow rate limiting device according to claim 1, wherein at least a part of the fluid passage is formed by the inner surface of the housing.

6. The flow rate limiting device according to claim 1, wherein an angle between any of the first part, the second part, and the third part of the fluid passage is between 45 degrees and 180 degrees.

7. The flow rate limiting device according to claim 1, wherein an angle between any of the first part, the second part, and the third part of the fluid passage is 90 degrees.

8. The flow rate limiting device according to claim 1, wherein the fluid passage has a fourth part extending in the second direction.

9. At least a part of the housing includes a transparent material, and either the third opening or the fourth opening of the fluid passage is engaged by being 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. The flow rate limiting device according to claim 1.

10. The insertion body includes a wall having a height extending in a direction away from the outer surface of the insertion body and a length extending around a part of either the third opening or the fourth opening of the fluid passage extending through the outer surface of the insertion body. The flow rate limiting device according to claim 1.

11. The flow rate limiting device according to claim 1, wherein the fluid passage has a cross-sectional area that decreases from the first end of the insertion body toward the second end of the insertion body.

12. The flow rate limiting device according to claim 1, wherein the fluid passage has a cross-sectional area that decreases from the second end of the insertion body toward the first end of the insertion body.

13. The flow rate limiting device according to claim 1, wherein either the third opening or the fourth opening of the fluid passage 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 inner surface forming a cavity between the first end portion and the second end portion, a first opening penetrating the first end portion to the cavity, and a second opening penetrating the second end portion to the cavity, An insertion 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, wherein the fluid passage has a first opening penetrating the first end of the insertion body, a second opening penetrating the second end of the insertion body, a third opening penetrating the outer surface, and a fourth opening penetrating the outer surface, and the fourth opening is spaced from the third opening, the flow rate limiting device comprising the insertion body, The insertion body is positioned within the cavity with the first opening of the fluid passage in fluid communication with the first opening of the housing, the second opening of the fluid passage in fluid communication with the second opening of the housing, and the third opening blocked by the inner surface of the housing, the flow rate limiting device.

15. The fourth opening is spaced from the third opening in a direction parallel to the longitudinal axis extending through the first end and the second end of the insertion body, the flow rate limiting device according to claim 14.

16. The fourth opening is spaced from the third opening radially around the longitudinal axis extending through the first end and the second end of the insertion body, the flow rate limiting device according to claim 14.

17. A portion along either the third opening or the fourth opening of the fluid passage is formed by the inner surface of the housing, the flow rate limiting device according to claim 14.

18. The fluid passage has a fifth opening penetrating the outer surface, and any one of the third opening, the fourth opening, and the fifth opening is spaced apart from each other relative to the longitudinal axis extending through the first end portion and the second end portion of the insertion body. The flow rate limiting device according to claim 14.

19. The housing has a window extending through the outer surface of the housing between the first end portion and the second end portion of the housing, and any one of the third opening and the fourth opening of the fluid passage is aligned with the window so that the fluid passage is visible through the window. The flow rate limiting device according to claim 14.

20. The insertion body includes a wall having a height extending in a direction away from the outer surface of the housing and a length extending around any one of the third opening and the fourth opening penetrating the outer surface. The flow rate limiting device according to claim 19.

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