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] This application relates to a flow restriction adapter for limiting hemolysis. Background Art

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

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

[0004] To verify the correct placement of the introducer needle and / or catheter in a blood vessel, a clinician typically confirms the presence of "backflow" of blood in the return lumen 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] To draw blood from a patient or collect a blood sample, a blood collection device can be used. The blood collection container can include a syringe. Alternatively, the blood collection container can include a test tube having a rubber stopper at one end. In some cases, the test tube has had 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 commonly referred to as internal vacuum tubes or vacuum tubes. A commonly used blood collection container is a blood collection tube (trademarked VACUTAINER), which can be obtained from Becton Dickinson & Company.

[0006] The blood collection container can 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 the blood into the blood collection container, thereby filling the blood collection container with blood. The vacuum inside the blood collection container decreases as the blood collection container is filled until the pressure in the blood collection container is equal to the pressure in the vein and the flow of blood stops.

[0007] In some cases, when blood is drawn into a blood collection container, due to the flow rate and geometry through the blood collection system, red blood cells may be subject to high shear stress and are prone to hemolysis. Hemolysis may result in the rejection and discard of the blood sample. Blood draw may also create a region of local negative pressure at the catheter tip, which may cause the catheter tip to collapse, the vein to collapse, or other complications that prevent or limit blood filling of the blood collection container. In addition, blood spillage may occur during and / or after blood draw.

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

[0009] Embodiments of a flow restriction adapter configured to limit, reduce, or prevent the occurrence of hemolysis are provided herein. In some embodiments, the flow restriction 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 that includes a proximal end positioned between the male Luer and the female Luer, an intermediate portion extending through the first cavity, a distal end positioned distal to the female Luer, and an inner lumen extending from the second cavity through the distal end of the strut.

[0010] Some embodiments provide a flow restriction adapter that includes: a first connector portion that 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 that includes a second connector end and an inner surface forming a second cavity; and a strut that includes a proximal end located at the first cavity bottom, an intermediate portion extending through the first cavity, a distal end positioned distal to the first connector end, and an inner lumen extending from the second cavity through the distal end of the strut.

[0011] In some embodiments, a peripheral intravenous catheter assembly is provided that is configured to limit hemolysis during blood draw from a patient. Some embodiments of these assemblies include a blood collection tube and a flow restriction adapter, wherein the first connector portion of the flow restriction adapter is configured to be coupled to the blood collection tube such that the tube of the flow restriction adapter extends into the blood collection tube, and the second connector of the flow restriction adapter is couplable to 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 the blood moving through the flow restriction device.

[0012] It should be understood that from the following detailed description, those skilled in the art will readily understand other configurations of the subject technology, where various configurations of the subject technology are shown and described by way of illustration. As will be recognized, the subject technology is capable of having other and different configurations and several details thereof can be modified in various other aspects, all without departing from the scope of the subject technology. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

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

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

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

[0016] Figure 3 There is shown according to some embodiments of the present disclosure Figure 2 a cross-sectional view of the flow restriction adapter.

[0017] Figure 4A There is shown according to some embodiments of the present disclosure Figure 2 a front view of the flow restriction adapter in a first position relative to a fluid collection device.

[0018] Figure 4B There is shown according to some embodiments of the present disclosure Figure 2 a front view of the flow restriction adapter in a second position relative to a fluid collection device.

[0019] Figure 5 There is shown Figure 4B a detailed cross-sectional view of the flow restriction adapter and the 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 may be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of the subject technology. Accordingly, dimensions may be provided with respect to certain aspects as non-limiting examples. However, it will be apparent to those skilled in the art that the subject technology may be practiced without these specific details.

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

[0022] Compared with traditional methods of blood extraction using venipuncture, blood extraction via a vascular access device has received increasing attention due to the minimization of needle insertion and the improvement of operational efficiency. Currently, there are some challenges in using a peripheral intravenous catheter (PIVC) for blood extraction, and one of the most critical challenges is the blood quality related to hemolysis. In particular, for PIVC products currently 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 directed to systems and methods for addressing hemolysis in PIVC blood extraction using a hemolysis reduction accessory in the form of a flow restriction adapter that can be attached to a PIVC or other fluid transfer device to reduce or limit the flow of fluid (such as blood) therethrough and reduce the risk of hemolysis. The hemolysis reduction accessory is advantageously compatible with PIVC placement and does not require any change to existing 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 existing blood collection devices and infusion components.

[0024] Various embodiments of the present disclosure focus on effective flow restriction using an additional hemolysis reduction flow restriction adapter that regulates the total flow rate of the entire fluid path when 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 blood extraction, the clinician can disconnect and discard the flow restriction adapter, or leave it coupled to the PIVC. Thus, such a flow restriction adapter can be used for single blood extraction or remain in series throughout the indwelling process.

[0025] The flow restriction adapters and related blood collection systems of the various embodiments described herein also provide advantages over existing blood collection systems. For example, the flow restriction 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 restriction adapters described herein are compatible with PIVC connectors and allow seamless blood draw upon insertion. Further, since the flow restriction adapters can be easily incorporated without any changes to existing PIVCs or blood collection containers, the impact on clinical settings and operations is minimal. Additionally, the ability to couple the flow restriction 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 according to some embodiments of the present disclosure is shown, which includes a PIVC assembly 50, as well as a blood collection device 40 and a flow restriction adapter 100. The flow restriction adapter 100 can be configured to facilitate the connection between the vascular access device 10 and the blood collection device 40 to reduce the likelihood of hemolysis during the movement of blood from a blood vessel into the device 10 and towards the blood collection device 40.

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

[0028] The blood collection device 40 can 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 to a PIVC, and a needle 47 configured to insert the blood collection tube 45, which is inserted into the blood collection tube holder 42.

[0029] In some embodiments, the catheter assembly 50 can include or correspond to any suitable catheter assembly 50. In some embodiments, the catheter assembly 50 can incorporate and include an extension tube 60, which can extend from and 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 trademark TMA closed IV catheter system that can be obtained from Becton Dickinson. 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, the flow - restricting adapter 100 can be fluidly coupled to the Y - adapter 70.

[0030] In some embodiments, the catheter assembly 50 can be non - integrated and can not include the extension tube 60. In these and other embodiments, the flow - restricting adapter 100 can be configured to be coupled to the proximal end 56 of the catheter hub 52 or another suitable portion of the catheter assembly 50. In some embodiments, the flow - restricting adapter 100 can be directly coupled 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 - restricting adapter 100 is shown, and Figure 3 is shown Figure 2 a cross - sectional view of the flow - restricting adapter 100 taken along line 3 - 3. The flow - restricting adapter 100 is configured to be fluidly coupled to the blood collection device 40 to limit the rate of fluid flow therethrough, thereby limiting hemolysis. The flow - restricting adapter 100 can be directly coupled to the blood collection device 40, such as by coupling to the blood collection tube holder 42, or the flow - restricting adapter 100 can be coupled along another portion of the fluid pathway for blood collection.

[0032] To couple the flow - restricting adapter 100 to the blood collection device 40 or another portion of the fluid pathway, the flow - restricting adapter 100 includes a first connector portion 110 and a second connector portion 112. For example, as Figure 1 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 located on opposite sides of the flow - restricting 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 can be offset relative to each other and the longitudinal axis A1. In some embodiments of the present disclosure, the first connector end 114 can be laterally oriented relative to the second connector portion 112 such that the fluid pathway of the first connector portion 110 is transverse to the fluid pathway of the second connector portion 112, or in a different direction.

[0034] The first connector portion 110 includes a first connector end 114, an inner surface 116, and a first cavity bottom 118 that form a first cavity 119 extending through the first connector end 114. The first cavity 119 of the flow restriction 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 the mating connector that is inserted through the first connector end 114 into the first cavity 119 and forms a fluid-tight seal therebetween.

[0035] To receive the mating connector into the first cavity of the first connector portion 110 and to 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 strut 140 extends through the first cavity of the first connector portion 110 and through the first connector end 114. When the first connector portion 110 is coupled to a blood collection device 40 such as an access device (LLAD) with the trademark BD LuerLok TM the strut 140 is configured to be positioned inside the needle 47 of the blood collection tube holder 42. The strut 140 also forms part of a fluid passage through the flow restriction adapter 100 that is configured to reduce the potential occurrence of hemolysis by reducing the flow rate of blood moving past the strut 140.

[0037] The strut 140 includes a proximal end 142, a distal end 144, and an intermediate 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 intermediate portion 146 of the strut extends through the first cavity formed by the first connector portion 110. The intermediate portion 146 extends completely through the first connector end 114 such that the distal end 144 of the strut is positioned outside the first connector portion 110.

[0038] To provide a strut 140 having a distal end 144 located outside the first connector portion 110 (i.e., away from the first connector end 114), the length of the strut 140 is greater than the length of the first connector portion 110. Refer to Figure 3, the first connector end 114 is positioned at a first distance D1 from the bottom 118 of the first cavity, and the distal end 144 of the strut is at a second distance D2 from the bottom 118 of the first cavity, where the first distance D1 is less than the second distance D2. In some embodiments of the present disclosure, the first distance D1 is between approximately 10% and approximately 90% of the second distance D2. In some embodiments, the first distance D1 is between approximately 25% and approximately 75% of the second distance D2. In some embodiments, the first distance D1 is approximately 25% of the second distance D2, and in some embodiments, the first distance D1 is approximately 30% of the second distance D2. In an example of the present disclosure, the first distance D1 is approximately 50% or less smaller 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. Thus, when the first connector portion 110 of the flow restriction adapter is coupled to a mating connector such as a blood collection device 40, a portion of the mating connector is received 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 the direction from the proximal end 142 to the distal end 144 of the strut.

[0040] To form a fluid passage through the flow restriction 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 may extend through the distal end 144 of the strut or through another portion of the strut 140, such as an intermediate portion 146 of the strut. The inner lumen 150 defines a fluid passage or a portion thereof through the flow restriction adapter 100. The fluid passage along the inner lumen 150 has an inner lumen width D and an inner lumen length, which may 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 strut 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 be coupled to a mating connector such as a PIVC and direct fluid (e.g., blood) into the inner lumen 150 of the strut.

[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, embodiments are also contemplated by the present disclosure 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 towards 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 towards the second connector end 160. The collar 168 has an inner surface 170 that is spaced from the 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 inwardly to engage 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 Shown is the flow restriction adapter 100 coupled to the blood collection device 40. In Figure 4A the flow restriction adapter 100 is in a first position where the flow restriction adapter 100 is spaced from the blood collection device 40. The flow restriction adapter 100 is oriented with its longitudinal axis A1 and is aligned or coaxial with the longitudinal axis A2 of the needle 47. The flow restriction adapter 100 and / or the blood collection device 40 can be moved towards each other such that the strut 140 is inserted into the lumen of the needle 47 of the blood collection tube holder 42.

[0045] As the flow restriction adapter 100 and the blood collection device 40 are moved towards each other, the strut 140 extends within the needle 47 and the first connector portion 110 can be coupled to the mating connector of the blood collection tube holder 42. In Figures 4A - 5 the illustrated embodiment, the first connector portion 110 is a female Luer that is coupled to the male Luer of the blood collection tube holder 42 by threads of the first connector portion 110 and the blood collection tube holder 42.

[0046] Referring to Figure 5 shows Figure 4BDetailed cross-sectional view of the flow restriction adapter 100 and the blood collection device, where the blood collection tube 45 is positioned within the blood collection tube holder 42. The movement of blood is shown by arrow B1, which moves through the inner lumen 150 in a direction from the second connector portion 112 towards the distal end 144 of the strut. The inner lumen 150 of the strut 140 provides a fluid passageway having a narrow diameter or cross-section to cause fluid resistance and reduce or limit hemolysis of the blood flowing therethrough. Additionally, the features of the flow restriction adapter 100 provide a device for restricting fluid flow to limit hemolysis, which can be implemented with existing devices. Further, since it is not necessary to insert the strut 140 into the PIVC, the flow restriction adapter 100 provides features for restricting flow to limit hemolysis while reducing the risk of infection.

[0047] The flow restriction adapter of the present disclosure also provides advantages over existing blood collection systems. For example, the flow restriction adapter described herein allows for the integration of hemolysis reduction functionality for PIVC blood draws. Additionally, the flow restriction adapter described herein is compatible with PIVC placement and allows for seamless blood draws upon insertion. In some embodiments, for multiple blood draws, the flow restriction adapter has the potential to remain in series throughout the PIVC indwelling. Further, since the flow restriction adapter can be added and can be easily incorporated without any changes to the existing PIVC, the impact on the clinical setting and operations is very small.

[0048] The optimized fluid passageway (which can include the inner lumen 150) can be configured to provide a restricted flow rate for reducing hemolysis and can have features including but not limited to a tubular fluid passageway, a cannula, a lumen, a continuous non-linear channel, a continuous linear channel, a groove, a fluid channel, etc.

[0049] The length of the fluid passageway 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 passageway can include the length L from the first connector portion 110 to the second connector portion 112. In some embodiments, the optimized fluid passageway can include the inner diameter D. In some examples of the present disclosure, the optimized fluid passageway has the length L from the first connector end 114 to the bottom 118 of the first cavity.

[0050] The Poiseuille equation can be used to analyze the fluid flow through the fluid passageway therein:

[0051]

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

[0053] In some embodiments, the fluid passageway can have multiple segments with lengths (L1, L2, L3) and inner diameters (D1, D2, D3). The geometric factor is:

[0054]

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

[0056]

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

[0058] In some embodiments, and by way of non-limiting example, the fluid passageway can 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 aspects of the present subject matter are described below. These are provided only as examples and do not limit the present subject matter. It should be noted that any of the following examples can be combined in any combination.

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

[0061] Wherein, the first connector portion includes a first cavity bottom forming part of the cavity, one end of the female Luer fitting 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, 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 strut defines a cross-sectional profile transverse to a longitudinal axis of the strut extending between the proximal end and the distal end of the strut, and the cross-sectional profile of the strut defines 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.

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

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

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

[0067] Further comprising a collar extending along the male Luer fitting, wherein the collar includes an inner surface spaced apart from the outer surface of the male Luer.

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

[0069] Wherein, the second cavity defines a second cavity width, and the second cavity width decreases in a direction from one end of the male Luer fitting towards the female Luer fitting.

[0070] A flow restriction adapter for limiting hemolysis, the flow restriction adapter comprising: a first connector portion including 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 including a proximal end located at the first cavity bottom, an intermediate portion extending through the first cavity, a distal end located away from the first connector end, and an inner lumen extending from the second cavity through the distal end of the strut.

[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 end and the distal end of the strut with respect to 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] Wherein, the strut width decreases in a direction from the proximal end of the strut towards the distal end of the strut.

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

[0076] Wherein, the 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 towards the first cavity bottom.

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

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

[0079] Wherein, the second cavity defines a second cavity width, and the second cavity width decreases in a direction from one end of the second connector portion towards the first connector portion.

[0080] This disclosure is provided to enable those of ordinary skill in the art to practice the various aspects described herein. This disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Numerous modifications to these aspects will be apparent to those of ordinary skill in the art, and the general principles defined herein may be applied to other aspects.

[0081] Unless otherwise specified, the use of the singular form of an element is not intended to mean "one and only one" but "one or more." Unless otherwise specified, the term "some" means one or more. Masculine pronouns (e.g., "his") include feminine and neuter genders (e.g., "her" and "its"), and vice versa. The use of headings and subheadings (if any) is for convenience only and does not limit this disclosure.

[0082] The word "exemplary" is used herein to mean "serving as an example or illustration." Any aspect or design described herein as "exemplary" need not 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 (separated by the term "or" in any of the items) modifies the entire list rather than each member of the list. The phrase "at least one" does not require the selection of at least one of the items; rather, the phrase allows for the meaning of including at least one of any one of the items, and / or at least one of any combination of the items, and / or at least one of each item. By way of example, the phrase "at least one of A, B, or C" can mean: only A, only B, or only C; or any combination of A, B, and C.

[0084] Phrases such as "aspect" do not imply that such an aspect is essential to the subject technology or that such an aspect applies to all configurations of the subject technology. The disclosure related to an aspect can apply to all configurations or one or more configurations. An aspect can provide one or more examples. The phrase "an aspect" can refer to one or more aspects and vice versa. Phrases such as "embodiment" do not imply that such an embodiment is essential to the subject technology or that such an embodiment applies to all configurations of the subject technology. The disclosure related to an embodiment can apply to all embodiments or one or more embodiments. An embodiment can provide one or more examples. The phrase "an embodiment" can refer to one or more embodiments and vice versa. Phrases such as "configuration" do not imply that such a configuration is essential to the subject technology or that such a configuration applies to all configurations of the subject technology. The disclosure related to a configuration can apply to all configurations or one or more configurations. A configuration can provide one or more examples. The phrase "such a configuration" can refer to one or more configurations and vice versa.

[0085] In one aspect, unless otherwise specified, all measurements, numerical values, ratings, positions, sizes, dimensions, and other specifications set forth in this specification, including those 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 they relate to and with the customs of the field to which they belong.

[0086] It should be understood that the particular order or hierarchy of steps or operations in the disclosed processes or methods is an illustration of exemplary methods. Based on implementation preferences or scenarios, it should be understood that the particular 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 can be performed or not performed. Some or all of the steps, operations, or processes can be automated without user intervention. The appended method claims present the elements of various steps, operations, or processes in an exemplary order and are not meant to be limited to the particular order or hierarchy presented.

[0087] All structural and functional equivalents of the elements across the various aspects described in this disclosure are known to those of ordinary skill in the art or will later become known to those of ordinary skill in the art, which are expressly incorporated herein by reference and are intended to be covered by the claims. Additionally, nothing disclosed herein is dedicated to the public, whether or not such disclosure is explicitly recited in the claims. No element of any claim can be construed under the provisions of 35 U.S.C. § 112(f), unless the element is expressly recited using the phrase "means for...", or in the case of a method claim, the element is recited using the phrase "step for...". Further, with respect to the scope of the terms "comprising", "having", etc. used, such terms are intended to be inclusive in a manner similar to the term "comprising" as interpreted when used as a transitional term in a claim.

[0088] The title, background, summary, brief description of the drawings, and abstract of the present disclosure are hereby incorporated into the present disclosure and are provided as illustrative examples of the present disclosure, rather than as a limiting description. The filing of this application is based on the understanding that they will not be used to limit the scope or meaning of the claims. Additionally, in the detailed description, it can be seen that the description provides illustrative examples, and for the purpose of simplifying the present disclosure, various features are combined together in various embodiments. The disclosed method should not be construed as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Instead, as reflected in the following claims, the utility model subject matter lies in less than all of the features of a single disclosed construction or operation. The following claims are thus incorporated into the detailed description, with each claim standing alone as separately claimed subject matter.

[0089] The claims are not intended to be limited to the aspects described herein but rather to the full scope consistent with the language of the claims and include all legal equivalents. Nevertheless, all claims are not intended to cover subject matter that fails to meet the requirements of 35 U.S.C. § 101, 102, or 103, nor should they be construed in such a way.

Claims

1. A flow restriction adapter for limiting hemolysis, characterized in that The flow restriction adapter comprises: 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, characterized in that 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, characterized in that The first distance is 50% or less of the second distance.

4. The flow restriction adapter according to claim 1, characterized in that: 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 according to claim 4, characterized in that The strut width decreases in a direction toward the distal end of the strut.

6. The flow restriction adapter according to 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 according to 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 restriction adapter according to claim 1, wherein: 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.

9. The flow restriction adapter according to 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 according to 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, characterized in that: The flow restriction adapter comprises: 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 according to 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 according to claim 12, wherein: The first distance is 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 according to 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 restrictor 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 restrictor 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, wherein: 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.

19. The flow restrictor 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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