Flow limiting adapter for limiting hemolysis

Abstract

A flow restricting adapter for restricting hemolysis may include first and second connector portions to allow coupling of the adapter to restrict flow between a catheter and a blood collection device, and a strut forming an inner lumen for directing blood through the flow restricting device, and a strut having a length configured to extend through the first connector portion and to be positioned within a portion of a blood collection device, such as a needle of a blood collection tube holder, the strut has an inner lumen that increases flow resistance and reduces shear stress of blood moving through the flow restricting device, thereby reducing the incidence of hemolysis.

Description

Technical Field

[0001] The present application relates to a flow restriction adapter for limiting hemolysis. Background Art

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

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

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

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

[0006] The blood collection container may be coupled to the catheter. When the blood collection container is coupled to the catheter, the pressure in the vein is higher than the pressure in the blood collection container, which pushes blood into the blood collection container, thereby filling the blood collection container with blood. The vacuum within the blood collection container decreases as the blood collection container fills until the pressure in the blood collection container equals the pressure in the vein and the flow of blood stops.

[0007] In some cases, as blood is drawn into the blood collection container, due to the flow rate and geometry through the blood collection system, the red blood cells may be subject to high shear stress and susceptible to hemolysis. Hemolysis may cause the blood sample to be rejected and discarded. The blood draw may also create an area of ​​local negative pressure at the catheter tip, which may cause catheter tip collapse, vein collapse, or other complications that prevent or limit blood from filling the blood collection container. In addition, blood spillage may occur during and / or after the blood draw.

[0008] The description provided in the background section should not be admitted to be prior art merely because it is mentioned in or related to the background section.The background section may include information describing one or more aspects of the subject technology. Summary of the invention

[0009] Provided herein are embodiments of flow restricting adapters configured to limit, reduce, or prevent hemolysis. In some embodiments, the flow restricting adapter includes a first connector portion forming a female Luer having a first cavity, a second connector portion forming a male Luer having a second cavity, a strut including a proximal end positioned between the male Luer and the female Luer, a mid-portion extending through the first cavity, a distal end positioned distal to the female Luer, and an inner lumen extending from the distal end of the strut extending through the second cavity.

[0010] Some embodiments provide a flow restriction adapter, which includes: a first connector portion, the first connector portion includes a first connector end, an inner surface and a first cavity bottom, wherein the inner surface and the first cavity bottom form a first cavity; a second connector portion, the second connector portion includes a second connector end and an inner surface forming a second cavity; and a pillar, the pillar including a proximal end located at the bottom of the first cavity, a middle portion extending through the first cavity, a distal end positioned distal to the first connector end, and an inner tubular cavity extending from the second cavity through the distal end of the pillar.

[0011] In some embodiments, peripheral intravenous catheter assemblies are provided that are configured to limit hemolysis during the extraction of blood from a patient. Some embodiments of these assemblies include a blood collection tube and a flow restriction adapter, wherein a first connector portion of the flow restriction adapter is configured to couple with the blood collection tube such that the tube of the flow restriction adapter extends into the blood collection tube, and a second connector of the flow restriction adapter is coupleable with the catheter assembly, and wherein the tube of the flow restriction adapter provides a narrow fluid flow path for blood moving through the flow restriction adapter, thereby reducing the incidence of hemolysis by increasing flow resistance and reducing shear stress on blood moving through the flow restriction device.

[0012] It should be understood that from the following detailed description, those skilled in the art will easily understand other configurations of the subject technology, wherein the various configurations of the subject technology are shown and described by way of illustration. As will be appreciated, the subject technology can have other and different configurations and its several details can be modified in various other aspects, all without departing from the scope of the subject technology. Therefore, the drawings and detailed description are considered to be illustrative rather than restrictive in nature. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0014] Figure 1 A vascular access device including a peripheral intravenous catheter (PIVC) assembly including a flow restricting adapter for limiting hemolysis is shown according to some embodiments of the present disclosure.

[0015] Figure 2 A front view of a flow restrictor adapter according to some embodiments of the present disclosure is shown.

[0016] Figure 3 Some embodiments of the present disclosure are shown Figure 2 Cross-sectional view of a flow restriction adapter.

[0017] Figure 4A Some embodiments of the present disclosure are shown Figure 2 A front view of a flow restrictor adapter in a first position relative to a fluid collection device.

[0018] Figure 4B Some embodiments of the present disclosure are shown Figure 2 A front view of a flow restrictor adapter in a second position relative to a fluid collection device.

[0019] Figure 5 Shows Figure 4B Detailed cutaway view of a flow restriction adapter and fluid collection device. DETAILED DESCRIPTION

[0020] 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 can be practiced. The specific embodiments include specific details for the purpose of providing a thorough understanding of the subject technology. Therefore, dimensions may be provided as non-limiting examples with respect to certain aspects. However, it is clear to those skilled in the art that the subject technology may be implemented without these specific details.

[0021] It should be understood that the present disclosure includes examples of subject technology and does not limit the scope of the appended claims. The following will illustrate various aspects of the subject technology according to specific but non-limiting examples. The various embodiments described in this disclosure can be implemented in different ways and variations and according to the intended application and implementation.

[0022] Compared with the traditional blood extraction method using venipuncture, blood extraction via vascular access devices has received increasing attention due to the minimization of needle penetration and the improvement of operating efficiency. Currently, there are some challenges in using peripheral intravenous catheters (PIVC) for blood extraction, one of the most critical challenges is blood quality related to hemolysis. In particular, for PIVC products currently available on the market, together with standard connectors (such as short extension kits and needleless connectors) and blood collection devices, the shear stress applied to red blood cells may cause hemolysis.

[0023] Various embodiments of the present disclosure are intended to provide systems and methods for addressing hemolysis in PIVC blood draws using a hemolysis reduction accessory in the form of a flow restricting adapter that can be attached to a PIVC or other fluid transfer device to reduce or restrict the flow of fluid (e.g., blood) therethrough and reduce the risk of hemolysis. The hemolysis reducing accessory is advantageously compatible with PIVC placement and does not require any changes to existing operations. The hemolysis reducing accessories of various embodiments described herein are potentially suitable for use with a wide variety of PIVC products and are compatible with existing blood collection devices and infusion components.

[0024] Various embodiments of the present disclosure focus on effective flow restriction using an additional hemolysis-reducing flow restriction adapter that regulates the total flow rate of the entire fluid path as blood travels through the flow restriction adapter. The flow restriction adapter can be provided separately or assembled or co-packaged with any PIVC and / or blood collection device. The clinician can connect the blood collection device to the port or connection portion of the flow restriction adapter and then draw blood to a predetermined volume. After the blood is drawn, the clinician can disconnect and discard the flow restriction adapter or leave it connected to the PIVC. Therefore, this flow restriction adapter can be used for a single blood draw or remain in series throughout the indwelling process.

[0025] The various embodiments of the flow restrictor adapters and associated blood collection systems described herein also provide advantages over existing blood collection systems. For example, the flow restrictor adapters described herein can reduce hemolysis while allowing blood to be drawn through an already placed PIVC and can be used with existing blood collection containers. In addition, the flow restrictor adapters described herein are compatible with PIVC connectors and allow for seamless blood drawing upon insertion. Furthermore, because the flow restrictor adapters can be easily incorporated without requiring any changes to the existing PIVC or blood collection containers, the impact on clinical settings and operations is minimal. Furthermore, the ability to couple the flow restrictor adapters of the present disclosure to existing PIVC systems and blood collection devices or containers provides an effective and low-cost solution for reducing hemolysis.

[0026] Figure 1 A vascular access device 10 is shown according to some embodiments of the present disclosure, comprising a PIVC assembly 50, as well as a blood collection set 40 and a flow restrictor adapter 100. The flow restrictor adapter 100 can be configured to facilitate connection between the vascular access device 10 and the blood collection set 40 to reduce the likelihood of hemolysis during movement of blood from the vascular access device 10 to the blood collection set 40.

[0027] In some embodiments, the vascular access device 10 may include a catheter assembly 50. The catheter assembly 50 includes a catheter hub 52, which may include a distal end 54, a proximal end 56, and a lumen extending through the distal end and the proximal end. The catheter assembly 50 may also include a catheter 58, which may be fixed within the catheter hub 52 and may extend distally from the distal end 54 of the catheter hub 52. In some embodiments, the catheter assembly 50 may be a PIVC.

[0028] The blood collection set 40 may include a blood collection tube holder 42 and a blood collection tube 45. The blood collection tube holder 42 includes an inlet port configured to be fluidly coupled with a PIVC, and a needle 47 configured to be inserted into the blood collection tube 45 inserted into the blood collection tube holder 42.

[0029] In some embodiments, the catheter assembly 50 may include or correspond to any suitable catheter assembly 50. In some embodiments, the catheter assembly 50 may integrate and include an extension tube 60 that may extend from and be integrated with the side port 59 of the catheter hub 52. A non-limiting example of an integrated catheter assembly is the BD NEXIVA TMA closed IV catheter system, which is available from Becton Dickinson, Inc. In some embodiments, the proximal end of the extension tube 60 can be coupled to an adapter, such as a Y-adapter 70. In some embodiments, a flow restrictor adapter 100 can be fluidly coupled to the Y-adapter 70.

[0030] In some embodiments, the catheter assembly 50 may be non-integrated and may not include the extension tube 60. In these and other embodiments, the flow restrictor adapter 100 may be configured to couple to the proximal end 56 of the catheter hub 52 or another suitable portion of the catheter assembly 50. In some embodiments, the flow restrictor adapter 100 may be coupled directly to the catheter assembly 50, thereby eliminating the extension tube 60 and providing a compact catheter system.

[0031] Figure 2 A front view of the flow restriction adapter 100 is shown, and Figure 3 Shows Figure 2 3-3 of the flow restriction adapter 100. The flow restriction adapter 100 is configured to be fluidly coupled to the blood collection set 40 to limit the rate at which fluid flows therethrough, thereby limiting hemolysis. The flow restriction adapter 100 can be coupled directly to the blood collection set 40, such as by coupling to the blood collection tube holder 42, or the flow restriction adapter 100 can be coupled along another portion of the fluid pathway for blood collection.

[0032] In order to couple the flow restrictor adapter 100 to the blood collection set 40 or another portion of a fluid pathway, the flow restrictor adapter 100 includes a first connector portion 110 and a second connector portion 112. For example, Figure 1 As shown, the first connector portion 110 can be coupled to the blood collection tube holder 42 , while the second connector portion 112 can be coupled to the Y-adapter 70 or another portion of the catheter assembly 50 .

[0033] The first and second connector portions 110, 112 are positioned on opposite sides of the flow restrictor adapter 100 and are axially aligned along a longitudinal axis A1 defined between the first and second connector portions 110, 112. However, in some embodiments of the present disclosure, it is contemplated that the first and second connector portions 110, 112 may be positioned offset relative to each other and the longitudinal axis A1. In some embodiments of the present disclosure, the first connector end 114 may be oriented transversely relative to the second connector portion 112, such that the fluid passageway of the first connector portion 110 is transverse to the fluid passageway of the second connector portion 112, or in different directions.

[0034] The first connector portion 110 includes a first connector end 114, an inner surface 116, and a first cavity bottom 118, which form a first cavity 119 extending through the first connector end 114. The first cavity 119 of the flow restrictor adapter 100 is configured to receive a mating connector therein. The inner surface 116 of the first connector defines a first connector cavity width W1. The first connector cavity width W1 can be configured such that the inner surface 116 of the first connector portion abuts against a mating connector that is inserted into the first cavity 119 through the first connector end 114 and forms a fluid tight seal therebetween.

[0035] To receive the mating connector into the first cavity of the first connector portion 110 and form a fluid tight seal between the first connector portion 110 and the mating connector, in some embodiments, the first connector cavity width W1 can decrease in a direction from the first connector end 114 toward the first cavity bottom 118. In some embodiments of the present disclosure, the first connector portion 110 forms a female Luer fitting.

[0036] The support post 140 extends through the first cavity of the first connector portion 110 and through the first connector end 114. LuerLok TM When the blood collection device 40 of the blood collection tube holder 42 is connected to the access device (LLAD), the support 140 is configured to be positioned inside the needle 47 of the blood collection tube holder 42. The support 140 also forms a part of the fluid passage through the flow restricting adapter 100, which is configured to reduce the potential occurrence of hemolysis by reducing the flow rate of blood moving through the support 140.

[0037] The strut 140 includes a proximal end 142, a distal end 144, and a middle portion 146 extending between the proximal end 142 and the distal end 144. The proximal end 142 is located at the first cavity bottom 118, and the middle portion 146 of the strut extends through the first cavity formed by the first connector portion 110. The middle portion 146 extends completely through the first connector end 114, so that the distal end 144 of the strut is positioned outside the first connector portion 110.

[0038] In order to provide the strut 140 with a distal end 144 located outside of the first connector portion 110 (ie, away from the first connector end 114), the length of the strut 140 is greater than the length of the first connector portion 110. Figure 3, the first connector end 114 is positioned at a first distance D1 from the first cavity bottom 118, and the distal end 144 of the strut is at a second distance D2 from the first cavity bottom 118, wherein the first distance D1 is less than the second distance D2. In some embodiments of the present disclosure, the first distance D1 is between about 10% and about 90% of the second distance D2. In some embodiments, the first distance D1 is between about 25% and about 75% of the second distance D2. In some embodiments, the first distance D1 is about 25% of the second distance D2, and in some embodiments, the first distance D1 is about 30% of the second distance D2. In examples of the present disclosure, the first distance D1 is about 50% or less than the second distance D2.

[0039] The outer surface of the strut 140 defines a cross-sectional profile transverse to the longitudinal axis A1, and the cross-sectional profile of the strut defines a strut width W2. The strut width W2 is less than the first connector cavity width W1, such that the outer surface of the strut 140 is spaced apart from the inner surface 116 of the first connector portion 110. Therefore, when the first connector portion 110 of the flow restrictor adapter is coupled to a mating connector such as a blood collection set 40, a portion of the mating connector is accommodated between the outer surface of the strut 140 and the inner surface 116 of the first connector portion 110. In some embodiments of the present disclosure, the strut width W2 decreases in a direction from the proximal end 142 to the distal end 144 of the strut.

[0040] To form a fluid pathway through the flow restrictor adapter 100, the strut 140 includes an inner lumen 150 that extends through the strut 140 to the second connector portion 112. The inner lumen 150 can extend through the distal end 144 of the strut, or through another portion of the strut 140, such as the middle portion 146 of the strut. The inner lumen 150 defines a fluid pathway, or a portion thereof, through the flow restrictor adapter 100. The fluid pathway along the inner lumen 150 has an inner lumen width D and an inner lumen length, which can be equal to or approximately equal to the second distance D2.

[0041] The inner lumen 150 is fluidly coupled to the second connector portion 112 such that fluid (i.e., blood) can move from the second connector portion 112 and through the struts 140. The second connector portion 112 includes a second connector end 160 and an inner surface 162 that forms a second cavity 164. The second connector portion 112 is configured to couple with a mating connector, such as a PIVC, and direct fluid (e.g., blood) into the inner lumen 150 of the struts.

[0042] The inner surface 162 of the second cavity 164 defines a second cavity width W3. The second cavity width W3 is greater than the inner lumen width D; however, the present disclosure also contemplates embodiments where the second cavity width W3 is equal to the inner lumen width D. In some embodiments of the present disclosure, the second cavity width W3 decreases in a direction from the second connector end 160 toward the first connector portion 110.

[0043] The second connector portion 112 includes a collar 168 that extends circumferentially around the second connector portion 112 and extends along the length of the second connector portion 112 toward the second connector end 160. The collar 168 has an inner surface 170 that is spaced apart from an outer surface 172 of the second connector portion to receive at least a portion of a mating connector. The collar 168 may also include threads 174 that extend radially inward to engage with threads of the mating connector. In some embodiments of the present disclosure, the second connector portion 112 forms a male Luer fitting.

[0044] Figure 4A and Figure 4B Flow restrictor adapter 100 is shown coupled to blood collection set 40. Figure 4A , the flow restrictor adapter 100 is in a first position in which the flow restrictor adapter 100 is spaced apart from the blood collection set 40. The flow restrictor adapter 100 is oriented with the longitudinal axis A1 of the flow restrictor adapter 100 aligned or coaxial with the longitudinal axis A2 of the needle 47. The flow restrictor adapter 100 and / or the blood collection set 40 can be moved toward each other to insert the support post 140 into the lumen of the needle 47 of the blood collection tube holder 42.

[0045] As the flow restricting adapter 100 and the blood collection set 40 are moved toward each other, the strut 140 extends within the needle 47 and the first connector portion 110 can couple with a mating connector of the blood collection tube holder 42. Figure 4A-Figure 5 In the illustrated embodiment, the first connector portion 110 is a female Luer that couples to a male Luer of the blood collection tube holder 42 via threads of the first connector portion 110 and the blood collection tube holder 42 .

[0046] Reference Figure 5 , showing Figure 4BDetailed cross-sectional view of a flow restrictor adapter 100 and a blood collection set with a blood collection tube 45 positioned within a blood collection tube holder 42. Movement of blood is shown by arrow B1, which moves through the inner lumen 150 in a direction from the second connector portion 112 toward the distal end 144 of the strut. The inner lumen 150 of the strut 140 provides a fluid pathway having a narrow diameter or cross-section to induce fluid resistance and reduce or limit hemolysis of blood flowing therethrough. Additionally, features of the flow restrictor adapter 100 provide a device for restricting fluid flow to limit hemolysis that can be implemented with existing devices. Additionally, since the strut 140 does not need to be inserted into the PIVC, the flow restrictor adapter 100 provides features for restricting flow to limit hemolysis while reducing the risk of infection.

[0047] The flow restrictor adapters disclosed herein also provide advantages over existing blood collection systems. For example, the flow restrictor adapters described herein allow for the integration of hemolysis reduction functionality for PIVC blood draws. Furthermore, the flow restrictor adapters described herein are compatible with PIVC placement and allow for seamless blood draws upon insertion. In some embodiments, the flow restrictor adapters have the potential to remain in series throughout the PIVC placement for multiple blood draws. Furthermore, because the flow restrictor adapters can be additional and can be easily incorporated without requiring any changes to the existing PIVC, the impact on clinical setup and operation is minimal.

[0048] The optimized fluid pathway (which may include the inner lumen 150) may be configured to provide a restricted flow rate for reducing hemolysis and may have features including but not limited to tubular fluid pathways, cannulas, lumens, continuous non-linear channels, continuous linear channels, grooves, fluid channels, and the like.

[0049] The length of the fluid pathway can be selected based on one or more of the following factors: the specifications of a particular catheter, the configuration of a particular catheter assembly, or the clinical setting. In some embodiments, the optimized fluid pathway can include a length L from the first connector portion 110 to the second connector portion 112. In some embodiments, the optimized fluid pathway can include an inner diameter D. In some examples of the present disclosure, the optimized fluid pathway has a length L from the first connector end 114 to the first cavity bottom 118.

[0050] The flow of fluid through a fluid passage can be analyzed using the Poiseuille equation:

[0051]

[0052] where ΔP is the change in pressure gradient across the length of the fluid path, D and L are the inner diameter and length of the fluid path, respectively, and Since μ is the viscosity of the fluid and not part of the extended tube geometry, the geometry factor G f Defined as R f (Fluid resistance) is G f ,in,

[0053] In some embodiments, the fluid pathway may have multiple segments with lengths (L1, L2, L3) and inner diameters (D1, D2, D3). The geometric factors are:

[0054]

[0055] In some embodiments, the optimized fluid passage may have a cross-section with a non-circular or complex internal profile. The geometric factor can be determined by measuring the flow rate (Q) of a fluid of known viscosity (μ) at a given pressure (ΔP):

[0056]

[0057] G of optimized fluid path can be selected f value to reduce the maximum shear stress of each catheter size to be equal to or less than that of size BD 21G UltraTouch TM The maximum shear stress of the push-button blood collection kit. In some embodiments, the G of the fluid path can be selected f value to reduce the maximum shear stress of each catheter size to be equal to or less than that of size BD 25G UltraTouch TM Maximum shear stress of a push-button blood collection kit.

[0058] In some embodiments, and by way of non-limiting example, the fluid passageway may have a diameter of approximately 0.014 inches. In another non-limiting example, the cross-sectional area of ​​the fluid passageway is approximately 0.000152 square inches.

[0059] Various examples of various aspects of the subject technology are described below. These are provided only as examples and do not limit the subject technology. It should be noted that any of the following examples can be combined in any combination.

[0060] A flow restricting adapter for limiting hemolysis, the flow restricting adapter comprising: a first connector portion, the first connector portion forming a female Luer having a first cavity; a second connector portion, the second connector portion forming a male Luer having a second cavity; a strut, the strut comprising a proximal end positioned between the male Luer and the female Luer, a mid-portion extending through the first cavity, a distal end positioned away from the female Luer, and an inner lumen extending from the second cavity through the distal end of the strut.

[0061] Wherein, the first connector portion includes a first cavity bottom forming a part of the cavity, one end of the female Luer piece is positioned at a first distance from the first cavity bottom, and the distal end of the support is positioned at a second distance from the first cavity bottom, wherein the first distance is less than the second distance.

[0062] Wherein, the first distance is approximately 50% or less of the second distance.

[0063] Wherein: the outer surface of the support defines a cross-sectional profile transverse to the longitudinal axis of the support extending between the proximal end and the distal end of the support, and the cross-sectional profile of the support defines the width of the support; and the first cavity defines a first connector cavity width, wherein the support width is less than the first connector cavity width.

[0064] Wherein, the strut width decreases in a direction from the bottom of the first cavity toward the distal end of the strut.

[0065] Wherein, the outer surface of the support is spaced apart from the inner surface of the female Luer component.

[0066] Wherein, the inner surface of the female Luer component defines a first connector cavity width, and wherein the first connector cavity width decreases in a direction from one end of the female Luer component toward a bottom of the first cavity.

[0067] Also included is a collar extending along the male luer, wherein the collar includes an inner surface spaced apart from an outer surface of the male luer.

[0068] Wherein, the inner lumen defines an inner lumen width, and the second lumen defines a second lumen width, and wherein the inner lumen width is smaller than the second lumen width.

[0069] The second cavity defines a second cavity width, and the second cavity width decreases in a direction from one end of the male Luer piece toward the female Luer piece.

[0070] A flow restriction adapter for limiting hemolysis, the flow restriction adapter comprising: a first connector portion, the first connector portion comprising a first connector end, an inner surface and a first cavity bottom, wherein the inner surface and the first cavity bottom form a first cavity; a second connector portion, the second connector portion comprising a second connector end and an inner surface forming a second cavity; and a pillar, the pillar comprising a proximal end located at the bottom of the first cavity, a middle portion extending through the first cavity, a distal end positioned away from the first connector end, and an inner tubular cavity extending from the second cavity through the distal end of the pillar.

[0071] wherein the first connector end is positioned at a first distance from the first cavity bottom, and the distal end of the strut is positioned at a second distance from the first cavity bottom, and wherein the first distance is less than the second distance.

[0072] Wherein, the first distance is approximately 50% or less of the second distance.

[0073] Wherein: the outer surface of the strut defines a cross-sectional profile transverse to a longitudinal axis extending between the proximal and distal ends of the strut, and the cross-sectional profile of the strut defines a strut width; and the inner surface of the first connector portion defines a first connector cavity width; and wherein the strut width is less than the first connector cavity width.

[0074] Therein, the strut width decreases in a direction from the proximal end of the strut toward the distal end of the strut.

[0075] Wherein, an outer surface of the support column is spaced apart from an inner surface of the first connector portion.

[0076] Wherein an inner surface of the first connector portion defines a first connector cavity width, and wherein the first connector cavity width decreases in a direction from the first connector end toward the first cavity bottom.

[0077] Also included is a collar extending along the second connector portion, wherein the collar includes an inner surface spaced apart from an outer surface of the second connector portion.

[0078] Wherein, the inner lumen defines an inner lumen width, and the second lumen defines a second lumen width, and wherein the inner lumen width is smaller than the second lumen width.

[0079] The second cavity defines a second cavity width that decreases in a direction from one end of the second connector portion toward the first connector portion.

[0080] The present disclosure is provided to enable those skilled in the art to practice the various aspects described herein. The present disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Multiple modifications to these aspects are very clear to those skilled in the art, and the general principles defined herein can be applied to other aspects.

[0081] Unless otherwise specified, reference to an element in the singular is not intended to mean "one and only one," but rather "one or more." Unless otherwise specified, the term "some" refers to one or more. Pronouns in the masculine (e.g., his) include the feminine and neuter genders (e.g., her and its) and vice versa. Headings and subheadings, if any, are used for convenience only and do not limit the disclosure.

[0082] The word "exemplary" is used herein to mean "serving as an example or illustration." Any aspect or design described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other aspects or designs. In one aspect, the various alternative configurations and operations described herein may be considered to be at least equivalent.

[0083] As used herein, the phrase "at least one" preceding a list of items (with the term "or" separating any items) modifies the list as a whole rather than each individual member of the list. The phrase "at least one" does not require selection of at least one of the items; rather, the phrase allows for a meaning that includes at least one of any one item, and / or at least one of any combination of items, and / or at least one of each item. For example, the phrase "at least one of A, B, or C" may mean: only A, only B, or only C; or any combination of A, B, and C.

[0084] Phrases such as "aspects" do not mean that such aspects are essential to the subject technology, or that such aspects apply to all configurations of the subject technology. The disclosure associated with an aspect may apply to all configurations or one or more configurations. An aspect may provide one or more examples. Phrases such as "an aspect" may refer to one or more aspects, and vice versa. Phrases such as "embodiments" do not mean that such embodiments are essential to the subject technology, or that such embodiments apply to all configurations of the subject technology. The disclosure associated with an embodiment may apply to all embodiments or one or more embodiments. An embodiment may provide one or more examples. Phrases such as "an embodiment" may refer to one or more embodiments, and vice versa. Phrases such as "constructions" do not mean that such constructions are essential to the subject technology, or that such constructions apply to all configurations of the subject technology. The disclosure associated with a construction may apply to all configurations or one or more constructions. A construction may provide one or more examples. Phrases such constructions may refer to one or more constructions, and vice versa.

[0085] In one aspect, unless otherwise indicated, all measurements, values, ratings, positions, sizes, dimensions, and other specifications in this specification, including those set forth in the claims that follow, are approximate and not exact. In one aspect, they are intended to have a reasonable range consistent with the functions to which they are related and with the customary practices in the art to which they belong.

[0086] It should be understood that the specific order or hierarchy of steps or operations in the disclosed process or method is an illustration of an exemplary method. Based on implementation preferences or scenarios, it should be understood that the specific order or hierarchy of steps, operations or processes can be rearranged. Some steps, operations or processes can be performed simultaneously. In some implementation preferences or scenarios, certain operations may or may not be performed. Some or all of the steps, operations or processes can be performed automatically without user intervention. The attached method claims present the elements of various steps, operations or processes in an exemplary order and are not meant to be limited to the specific order or hierarchy presented.

[0087] All structural and functional equivalents of the elements of the various aspects described throughout the present disclosure are known or will be known to those of ordinary skill in the art in the future, and are expressly incorporated herein by reference and are intended to be covered by the claims. In addition, regardless of whether such disclosure is explicitly stated in the claims, the content disclosed herein is not intended to be committed to the public. No claim element can be interpreted according to the provisions of 35 U.S.C. § 112 (f) unless the element is explicitly stated using the phrase "means for...", or in the case of a method claim, the element is stated using the phrase "for..." step. In addition, for the scope of the terms "including", "having", etc. used, such terms are intended to refer to inclusiveness in a manner similar to the term "including", as explained when "including" is used as a transitional word in the claims.

[0088] The title, background technology, content, description of the drawings and abstract of the present disclosure are incorporated into the present disclosure and are provided as illustrative examples of the present disclosure, rather than restrictive descriptions. The submission of this application is based on the understanding that they will not be used to limit the scope or meaning of the claims. In addition, in the specific embodiments, it can be seen that the description provides illustrative examples, and in order to simplify the present disclosure, various features are combined together in various embodiments. This disclosure method should not be interpreted as reflecting the intention that the claimed subject matter requires more features than those explicitly stated in each claim. On the contrary, as reflected in the following claims, the subject matter of the invention lies in less than all the features of a single disclosed construction or operation. The claims below are therefore incorporated into the detailed description, and each claim is independently a subject matter claimed separately.

[0089] The claims are not intended to be limited to the aspects described herein but are to be accorded the full scope consistent with the language of the claims and including all legal equivalents. Nevertheless, all claims are not intended to include subject matter that fails to satisfy the requirements of 35 U.S.C. §101, 102, or 103 and should not be interpreted in such a manner.

Claims

1. A flow restriction adapter for limiting hemolysis, the flow restriction adapter comprising: a first connector portion forming a female Luer having a first cavity; a second connector portion forming a male luer having a second cavity; A strut includes a proximal end positioned between the male and female Luer members, a mid-portion extending through the first cavity, a distal end positioned distal to the female Luer member, and an inner lumen extending from the second cavity through the distal end of the strut.

2. The flow restriction adapter according to claim 1, wherein: The first connector portion includes a first cavity bottom forming a portion of the cavity, one end of the female Luer piece is positioned at a first distance from the first cavity bottom, and the distal end of the support is positioned at a second distance from the first cavity bottom, wherein the first distance is less than the second distance.

3. The flow restriction adapter according to claim 2, wherein: The first distance is approximately 50% or less of the second distance.

4. The flow restriction adapter of claim 1, wherein: an outer surface of the strut defining a cross-sectional profile transverse to a longitudinal axis of the strut extending between a proximal end and a distal end of the strut, and the cross-sectional profile of the strut defining a strut width; and The first cavity defines a first connector cavity width, wherein the strut width is less than the first connector cavity width.

5. The flow restriction adapter of claim 4, wherein: The strut width decreases in a direction toward the distal end of the strut.

6. The flow restriction adapter of claim 1, wherein: The outer surface of the strut is spaced apart from the inner surface of the female Luer.

7. The flow restriction adapter of claim 1, wherein: The inner surface of the female luer defines a first connector cavity width, and wherein the first connector cavity width decreases in a direction away from an end of the female luer.

8. The flow restrictor adapter of claim 1 further comprising a collar extending along the male luer, wherein: The collar includes an inner surface spaced apart from an outer surface of the male luer.

9. The flow restriction adapter of claim 1, wherein: The inner lumen defines an inner lumen width, and the second lumen defines a second lumen width, and wherein the inner lumen width is less than the second lumen width.

10. The flow restriction adapter of claim 1, wherein: The second cavity defines a second cavity width that decreases in a direction from an end of the male luer toward the female luer.

11. A flow restriction adapter for limiting hemolysis, the flow restriction adapter comprising: a first connector portion, the first connector portion comprising a first connector end, an inner surface, and a first cavity bottom, wherein the inner surface and the first cavity bottom form a first cavity; a second connector portion including a second connector end and an inner surface forming a second cavity; and A strut includes a proximal end located at the bottom of the first cavity, a midsection extending through the first cavity, a distal end located distal to the first connector end, and an inner lumen extending from the second cavity through the distal end of the strut.

12. The flow restriction adapter of claim 11, wherein: The first connector end is positioned at a first distance from the first cavity bottom, and the distal end of the strut is at a second distance from the first cavity bottom, and wherein the first distance is less than the second distance.

13. The flow restriction adapter of claim 12, wherein: The first distance is approximately 50% or less of the second distance.

14. The flow restrictor adapter of claim 11, wherein: an outer surface of the strut defining a cross-sectional profile transverse to a longitudinal axis of the strut extending between a proximal end and a distal end of the strut, and the cross-sectional profile of the strut defining a strut width; and An inner surface of the first connector portion defines a first connector cavity width; and Wherein, the width of the pillar is smaller than the width of the first connector cavity.

15. The flow restriction adapter of claim 14, wherein: The strut width decreases in a direction from the proximal end of the strut toward the distal end of the strut.

16. The flow restriction adapter of claim 11, wherein: An outer surface of the strut is spaced apart from an inner surface of the first connector portion.

17. The flow restriction adapter of claim 11, wherein: An inner surface of the first connector portion defines a first connector cavity width, and wherein the first connector cavity width decreases in a direction from the first connector end toward the first cavity bottom.

18. The flow restrictor adapter of claim 11, further comprising a collar extending along the second connector portion, wherein: The collar includes an inner surface spaced apart from an outer surface of the second connector portion.

19. The flow restriction adapter of claim 11, wherein: The inner lumen defines an inner lumen width, and the second lumen defines a second lumen width, and wherein the inner lumen width is less than the second lumen width.

20. The flow restrictor adapter of claim 11, wherein: The second cavity defines a second cavity width that decreases in a direction from an end of the second connector portion toward the first connector portion.

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