Hemolysis reduction accessory for direct blood draw

Abstract

To provide a flow restriction device.SOLUTION: A housing forming a fluid flow path with an elastic valve positioned between a first section and a second section of the fluid path; A section of the fluid pathway includes a helical or involute shape, and the elastic valve is responsive to changes in pressure along the fluid pathway such that the elastic valve can move or deflect toward the fluid pathway to restrict fluid flow through the fluid pathway, thereby reducing the flow rate and pressure of the fluid, but if the fluid is blood, reducing the rate of hemolysis of the blood, and in some instances the elastic valve stops fluid flow through the fluid flow pathway to reduce the rate of hemolysis of the blood in response to excessive pressure along the fluid pathway.SELECTED DRAWING: Figure 5

Description

[Technical Field]

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 341,418, filed May 12, 2022, entitled "HEMOLYSIS-REDUCTION ACCESSORIES FOR DIRECT BLOOD DRAW," the disclosure of which is incorporated herein by reference in its entirety.

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

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

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

[0005] To verify proper placement of the introducer needle and / or catheter within the blood vessel, clinicians typically confirm the presence of a "flashback" of blood within the flashback chamber of the catheter assembly. Once needle placement is confirmed, the clinician can temporarily occlude flow within the vasculature and remove the needle, leaving the catheter in place for future blood withdrawal or fluid injection.

[0006] A blood collection container may be used to withdraw blood from a patient or to collect a blood sample from a patient. The blood collection container may include a syringe. Alternatively, the blood collection container may include a test tube with a rubber stopper at one end. In some cases, the test tube has had all or a portion of the air removed from it so that the pressure within the tube is less than ambient pressure. Such blood collection containers are often referred to as internal vacuum or vacuum tubes. A commonly used blood collection container is the VACUTAINER® blood collection tube, available from Becton Dickinson & Company.

[0007] A blood collection container may be coupled to the catheter. When the blood collection container is coupled to the catheter, the pressure in the vein is greater than the pressure in the blood collection container. This forces blood into the blood collection container, causing it to fill with blood. The vacuum in the blood collection container decreases as the blood collection container fills, until the pressure in the blood collection container equals the pressure in the vein and blood flow stops. In some cases, blood is drawn into the collection container by pulling on the plunger of a syringe.

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

[0009] In some instances, pulling on the plunger of a syringe coupled to a catheter can unintentionally apply pressure to the blood, which can result in high shear stress on red blood cells and consequent hemolysis. Additionally, the process of pulling on the plunger of a syringe to draw blood into a blood collection container relies on control and skill exercised by the user and can therefore vary among different users.

[0010] The statements made in the Background section should not be considered prior art merely because they are mentioned in or associated with the Background section. The Background section may include information that describes one or more aspects of the subject technology. Summary of the Invention [Means for solving the problem]

[0011] The present disclosure provides a flow restrictor device comprising: a proximal housing including a first end portion forming a proximal port, a second end portion, and a passage extending through the first and second end portions; a distal housing including the first end portion, a second end portion forming a distal port, and a passage extending through the first and second end portions; a flow insert positioned within a cavity formed between the proximal and distal housings and including a fluid passage extending therethrough, the fluid passage including a first section formed by an outer surface of the flow insert and a second section formed by an inner surface of the flow insert; and a flow insert having a fluid passage extending therethrough, the fluid passage including a first section formed by an outer surface of the flow insert and a second section formed by an inner surface of the flow insert. and an elastomeric valve positioned between the proximal housing and including a first end having an inner portion and an outer portion, the inner portion being aligned with a second segment of the fluid passage of the flow insert and the outer portion being aligned with the first segment of the fluid passage of the flow insert, the inner portion of the elastomeric valve being flexible relative to the proximal housing such that in the first position of the elastomeric valve, the inner portion is spaced a first distance from the flow insert to allow fluid movement between the first and second segments of the fluid passage, and in the second position, the inner portion is spaced a second distance from the flow insert to prevent fluid movement between the first and second segments of the fluid passage.

[0012] In some instances, the disclosure provides a flow restrictor device, the flow restrictor device comprising: a flow insert including a fluid passageway extending therethrough, the fluid passageway including a first section defined by an outer surface of the flow insert and a second section defined by an inner surface of the flow insert; and a elastomeric valve including a first end forcibly engaged with the outer surface of the flow insert and an aperture extending through the elastomeric valve from the first end to a second end of the elastomeric valve, the first end aligned with the second section of the fluid passageway. and an elastomeric valve having an inner portion aligned with the first segment of the fluid passage and an outer portion aligned with the first segment of the fluid passage, the inner portion of the elastomeric valve being flexible relative to the flow insert such that in a first orientation of the elastomeric valve, the inner portion is spaced a first distance from the flow insert to allow fluid movement between the first and second segments of the fluid passage, and in a second orientation of the elastomeric valve, the inner portion is spaced a second distance from the flow insert to prevent fluid movement between the first and second segments of the fluid passage.

[0013] Various configurations of the subject technology have been shown and described by way of illustration, with the understanding that other configurations of the subject technology will be readily apparent to those skilled in the art from the following detailed description. As will be understood, the subject technology is capable of other and different configurations, and its several details can be modified in various other respects, all without departing from the scope of the subject technology. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature, and not as restrictive.

[0014] The following drawings are included to illustrate certain aspects of the embodiments and should not be considered exclusive examples. The disclosed subject matter is capable of considerable modification, permutation, combinations, and equivalents in form and function that will occur to those skilled in the art and having the benefit of this disclosure. [Brief explanation of the drawings]

[0015] [Figure 1]1 illustrates a vascular access device including a peripheral intravenous catheter (PIVC) assembly including a flow restriction device, according to some embodiments of the present disclosure. [Figure 2] FIG. 1 illustrates a perspective view of a flow restrictor device, according to some embodiments of the present disclosure. [Figure 3] 3 illustrates an exploded view of the flow restrictor of FIG. 2 according to some embodiments of the present disclosure. [Figure 4] 1A and 1B show perspective views of an insert body for a flow restrictor device according to some embodiments of the present disclosure. [Figure 5] 5 illustrates a cross-sectional view of the flow restrictor of FIG. 2 taken along line 5-5, according to some embodiments of the present disclosure. [Figure 6] FIG. 1 illustrates a perspective view of an elastic valve for a flow restrictor, according to some embodiments of the present disclosure. [Figure 7] FIG. 7 illustrates a cross-sectional view of the elastomeric valve of FIG. 7 taken along line 7-7, according to some embodiments of the present disclosure. [Figure 8] 1A-1C illustrate perspective views of a flow insert for a flow restrictor device according to some embodiments of the present disclosure. [Figure 9] 1A and 1B illustrate cross-sectional views of a flow restrictor device according to some embodiments of the present disclosure. [Figure 10] 1A-1C illustrate perspective views of a flow insert for a flow restrictor device according to some embodiments of the present disclosure. [Figure 11] 1A and 1B illustrate cross-sectional views of a flow restrictor device according to some embodiments of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0016] The detailed description set forth below describes various configurations of the subject technology and is not intended to represent the only configurations in which the subject technology may be practiced. The detailed description includes specific details to achieve a thorough understanding of the subject technology. Thus, dimensions may be given as non-limiting examples for certain embodiments. However, it will be apparent to those skilled in the art that the subject technology may be practiced without these specific details. In some instances, well-known structures and components are shown in block diagram form to avoid obscuring the concepts of the subject technology.

[0017] It should be understood that the present disclosure includes examples of the subject technology and is not intended to limit the scope of the appended claims. Various aspects of the subject technology will now be disclosed by way of specific examples, but not by way of limitation. The various embodiments described in this disclosure can be implemented in different ways and variations and depending on the desired application or implementation.

[0018] Blood collection via vascular access devices has attracted increasing attention due to the minimized needle stick and improved operational efficiency compared to traditional blood collection by venipuncture. Current blood collection using peripheral intravenous catheters (PIVCs) encounters several challenges, one of the most significant being blood quality related to hemolysis. In particular, the shear stress acting on blood cells by PIVC products currently on the market with standard connections (such as short extension sets and needleless connectors) and blood collection devices (such as vacutainers) tends to be on the verge of hemolysis.

[0019] Various embodiments of the present disclosure are directed to providing systems and methods for addressing hemolysis in PIVC blood collection using a hemolysis reduction accessory (also referred to herein as a flow restrictor) that can be pre-attached to a PIVC and reduce flow rates to reduce the risk of hemolysis. The hemolysis reduction accessory is advantageously compatible with PIVC configurations and does not require any modifications to current operations. The hemolysis reduction accessories of various embodiments described herein are potentially applicable to a wide variety of PIVC products and are compatible with current blood collection devices and infusion disposables.

[0020] Various embodiments of the present disclosure focus on effective flow reduction using an add-on hemolysis reduction accessory (also referred to herein as a flow restrictor), which regulates the overall flow rate of the entire fluid path through which blood cells travel. The flow restrictor may be assembled with or co-packaged with the PIVC. Thus, the device can tolerate blood flashback without further manipulation during catheter placement. The clinician can retrieve a blood collection device into a port or opening in the accessory and then draw blood into the volume of interest. After blood collection, the clinician can disconnect and discard the flow restrictor and blood collection device together. Thus, this flow restrictor can be for a single blood draw or can remain in-line throughout the entire placement.

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

[0022] The present disclosure further provides a flow restrictor device and associated blood collection system that can prevent hemolysis of blood due to high inlet pressure by reducing the cross-sectional area or closing the blood flow pathway to reduce the flow rate of blood moving therethrough when the inlet pressure exceeds a desired value or range. When the inlet pressure returns to the desired value or range, features of the present disclosure may allow the flow rate of blood through the blood flow pathway to be increased.

[0023] The flow restricting device of the present disclosure can include a surface forming a fluid passage and an elastomeric valve positioned adjacent to or along at least a portion of the fluid passage. At least a portion of the elastomeric valve can be moved or biased toward or away from the fluid passage. In a first orientation or position of the elastomeric valve, fluid, such as blood, can move along a fluid flow path that includes the surface forming the fluid passage and between the surface and the elastomeric valve. In a second orientation or position of the elastomeric valve, at least a portion of the valve is moved or biased toward the surface forming the fluid passage such that a cross-sectional area of ​​the fluid flow path between the surface and the elastomeric valve is reduced relative to the first orientation. In the second orientation, movement of fluid along the fluid flow path between the surface forming the fluid passage and the elastomeric valve is reduced or stopped relative to the first orientation.

[0024] In some embodiments of the present disclosure, a flow restrictor device can include a surface forming a fluid passage having a first segment and a second segment, and an elastomeric valve positioned adjacent to the fluid passage or between the first and second segments of the fluid passage, such that a fluid flow path extends between the elastomeric valve and the surface forming the fluid passage. In a first orientation of the elastomeric valve, fluid can travel along the fluid flow path between the first and second segments of the fluid passage, and in a second orientation, at least a portion of the valve is moved or biased toward the surface forming the fluid passage such that movement of fluid along the fluid flow path between the first and second segments is reduced relative to when the elastomeric valve is in the first orientation. In some embodiments of the present disclosure, movement of fluid along the fluid flow path between the first and second segments is blocked when the elastomeric valve is in the second orientation.

[0025] In some aspects of the present disclosure, the flow restrictor can include a housing that defines a cavity and at least a portion of the fluid flow path. The surface that defines the fluid passage can be formed by a surface of the housing, such as an inner surface, and the elastomeric valve can be positioned within the cavity of the housing. In some embodiments, the inner surface of the housing can define the fluid passage and the cavity, and the elastomeric valve is positioned within the cavity. Some embodiments of the present disclosure include a housing having an inner surface that defines the cavity, a elastomeric valve positioned within the cavity, and a flow insert positioned within the cavity and having a surface that defines at least a portion of the fluid passage.

[0026] The fluid passage, or a portion thereof, can extend in a linear or non-linear direction. In some embodiments, either the first segment or the second segment of the fluid passage extends in a linear direction, and the other of the first segment or the second segment of the fluid passage extends in a non-linear direction. The non-linear direction can form, for example, a helical or involute shape. The helical or involute-shaped fluid passage can form a portion of the first segment of the fluid passage that extends radially inward to the second segment of the fluid passage. The helical or involute shape of the fluid passage can extend about a longitudinal axis that passes through a central portion of the second segment of the fluid passage.

[0027] In some embodiments of the present disclosure, the fluid passageway or portions thereof may be angled between the segments, where the angle may be between approximately 0 degrees and approximately 180 degrees. In some embodiments, the angle between the segments is approximately 90 degrees.

[0028] FIG. 1 illustrates a vascular access device 10 including a peripheral intravenous catheter (PIVC) assembly 50, a flow restriction device 100, and a blood collection device 40, according to some embodiments of the present disclosure. The device illustrated in FIG. 1 can be used, for example, in a syringe blood draw procedure. The flow restriction device 100 can be configured to reduce the likelihood of hemolysis during blood draw using the vascular access device 10 and blood collection device 40. In some embodiments, the vascular access device 10 can include a catheter assembly 50. The catheter assembly 50 can include a catheter hub 52, which can include a distal end 54, a proximal end 56, and a lumen extending through the distal and proximal ends. The catheter assembly 50 can further include a catheter 58, which can be secured within the catheter hub 52 and can extend distally from the distal end 54 of the catheter hub 52. In some embodiments, the catheter assembly 50 can be a peripheral intravenous catheter (PIVC).

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

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

[0031] FIG. 2 shows a perspective view of a flow restrictor 100 having a proximal housing 112 and a distal housing 114, according to some embodiments of the present disclosure. FIG. 3 shows an exploded view of a flow restrictor 100 having a proximal housing 112, a distal housing 114, an elastomeric valve 202, and a flow insert 302 configured to be positioned between the proximal housing 112 and the distal housing 114. FIG. 4 shows a perspective view of a flow restrictor 100 having a proximal housing 112 and a distal housing 114, which are shown as transparent to show the elastomeric valve 202 and the flow insert 302 positioned within the cavity between the proximal housing 112 and the distal housing 114. FIG. 5 shows a cross-sectional view of the flow restrictor 100 of FIG. 2 taken along line 5-5.

[0032] 2-5 , in some embodiments, the flow restriction device 100 includes a proximal housing 112 and a distal housing 114. The proximal housing 112 and the distal housing 114 each include a port configured to couple the fluid flow path of the flow restriction device 100 with other devices, such as the vascular access device 10, the blood collection device 40, and / or the catheter assembly 50. In some embodiments of the present disclosure, the distal housing 114 can include a first end portion 122 that forms a distal port 124 of the flow restriction device, and the proximal housing 112 can include a second end portion 162 that forms a proximal port 164 of the flow restriction device.

[0033] The distal port 124 may be configured to mate with a blood collection device, such as the vascular access device 10 or catheter assembly 50, and the proximal port 164 may be configured to mate with a blood collection device 40, such as a syringe. In some embodiments of the present disclosure, either the proximal port 164 or the distal port 124 may form either a male or female luer connector. In some embodiments, the proximal port 164 is formed as a female luer connector and the distal port 124 is formed as a male luer connector.

[0034] The distal port 124 may be formed by an inner surface 126 of the distal housing 114. The inner surface 126 defines a passageway 128 therethrough that extends from the first end portion 122 to the second end portion 130 of the distal housing.

[0035] The distal housing 114 can further include a wall 132 that, in some embodiments, forms the first end portion 122 and has an inner surface 134 that forms a female connector. The distal housing 114 can further include a protrusion 136 that extends along the distal housing first end portion 122 and is positioned radially inward from the inner wall surface 134 such that an outer surface 138 of the protrusion is spaced from the inner wall surface 134.

[0036] The protrusion 136 and the wall 132 form a connector for the flow restrictor device configured to couple with another device positioned between the inner surface 134 of the wall and the outer surface 138 of the protrusion, and the passage 128 of the distal housing extends through the protrusion 136.

[0037] In some embodiments of the present disclosure, the inner wall surface 134 may include a fastening structure configured to compressively engage and / or couple the flow restrictor device 100 with another device. In some aspects, the fastening structure of the distal housing 114 may be threads 140 extending along the inner wall surface 134. In some examples of the present disclosure, the fastening structure of the distal housing 114 may be the inner wall surface 134 configured to compressively engage and form an interference fit with another device.

[0038] Distal housing second end portion 130 has an interior surface that forms a bore that extends into the distal housing in a direction from second end portion 130 toward first end portion 122 to a recessed surface 142. Proximal housing passageway 128 extends through recessed surface 142 to the bore.

[0039] Distal housing second end portion 130 may further include a flow channel 144 configured to fluidly couple with passageway 128. Flow channel 144 extends to recessed surface 142 to define another portion of the fluid flow path through flow restrictor 100.

[0040] The flow channel 144 includes a first or proximal end 146 that intersects with the passageway 128 of the distal housing to fluidly couple the flow channel 144 with the passageway 128. The flow channel 144 extends away from, or radially outward from, the passageway 128. The flow channel 144 further includes a second or distal end 148 that is configured to fluidly couple with another portion of the fluid flow path of the flow restrictor 100.

[0041] The proximal housing 112 is configured to mate with the distal housing 114 to form another portion of the fluid flow path of the flow restrictor 100. The fluid flow path of the proximal housing 112 may include a proximal port 164. The proximal port is formed by an inner surface 166 of the proximal housing 112. The inner surface 166 defines a passageway 168 through the proximal housing, which extends from the first end portion 160 to the second end portion 162 of the proximal housing.

[0042] In some embodiments of the present disclosure, the first end portion 160 of the proximal housing has an inner surface that forms a bore extending into the proximal housing in a direction from the first end portion 160 toward the second end portion 162.

[0043] Proximal housing 112 and distal housing 114 are configured to form a cavity therebetween, the cavity being configured to receive elastomeric valve 202 and flow insert 302. In some embodiments of the present disclosure, elastomeric valve 202 and flow insert 302 are positioned between recessed surface 142 of the distal housing and first end portion 160 of the proximal housing. In some embodiments, elastomeric valve 202 and flow insert 302 are positioned within the cavity formed between proximal housing 112 and distal housing 114.

[0044] In some embodiments of the present disclosure, the exterior surface 170 of the second end portion of the proximal housing may include fastening structure configured to press against the flow restrictor 100 to engage and / or couple another device to the flow restrictor 100. In some aspects, the fastening structure of the proximal housing 112 may be threads 172 extending along the exterior surface 170 of the second end portion.

[0045] The elastomeric valve 202 is positioned between the proximal housing 112 and the distal housing 114 and is configured to block the movement of fluid along the fluid flow path of the flow restrictor 100. The elastomeric valve 202 shown in Figures 3-7 includes a first end 203 and a second end 204, with the second end 204 opposite the first end 203. Additionally, an inner portion 206 and an outer portion 208 extending around the inner portion 206 are defined along the first and second ends 203, 204 of the elastomeric valve. The inner portion 206 is flexible relative to the outer portion 208 such that when a force or pressure is applied to the elastomeric valve, the inner portion 206 can move or deflect.

[0046] In some embodiments of the present disclosure, the first end 203 of the elastomeric valve forms a convex surface along an inner portion 206, and the second end 204 of the elastomeric valve forms a concave surface along the inner portion 206. When the elastomeric valve 202 is positioned between the proximal housing 112 and the distal housing 114, the inner portion 206 along the second end 204 is aligned with the passageway 128 of the distal housing, and the inner portion along the first end 203 is aligned with another fluid passageway of the flow restrictor 100.

[0047] The elastomeric valve 202, in some embodiments, is shaped as a disk having a radial center 211 and an outer periphery 212 extending around the center. In some embodiments, an inner portion 206 is aligned with the center 211 of the elastomeric valve, and an outer portion 208 extends from the inner portion to the outer periphery 212 of the elastomeric valve.

[0048] The elastomeric valve 202 includes an aperture 210 that extends through the first and second ends 203, 204 and is configured to form a portion of the fluid flow path of the flow restrictor 100. The aperture 210 forms a portion of the fluid flow path that allows fluid to travel through the elastomeric valve 202.

[0049] It should be understood that although aperture 210 may be disposed along outer portion 208, the present disclosure contemplates aperture 210 positioned along either inner portion 206 and / or outer portion 208. In some embodiments of the present disclosure, a portion of the fluid flow path extends along either first end 203, second end 204, perimeter 212, and / or an outer surface of aperture 210.

[0050] To align the elastomeric valve 202 with another portion of the flow restrictor 100, the elastomeric valve 202 can include an alignment ridge 214. In some embodiments, the alignment ridge 214 extends from a surface of the first end 203 in a direction away from the second end 204. The alignment ridge 214 can be configured such that when the elastomeric valve 202 is positioned adjacent to the flow insert 302, the alignment ridge 214 can press against or be positioned within a complementary feature of the flow insert 302. In some embodiments, when the elastomeric valve 202 is positioned adjacent to the flow insert 302 and the alignment ridge 214 is positioned within or pressed against a complementary feature of the flow insert 302, the aperture 210 of the elastomeric valve aligns with and / or intersects with a portion of the fluid flow path defined by the flow insert 302.

[0051] Referring to FIG. 7, the alignment ridge 214 is shown extending from the first end 203 of the elastomeric valve in a direction away from the second end 204 of the elastomeric valve. The alignment ridge 214 is shaped as an elongated wall having a width and a length. The width of the alignment ridge 214 extends from the center 211 toward the outer periphery 212 of the elastomeric valve, and the length of the alignment ridge 214 extends along the outer periphery 212 of the elastomeric valve. The shape of the alignment ridge 214 along the first end 203 of the elastomeric valve is shown by the dashed line B1 along the second end 204 of the elastomeric valve in FIG. 6 for reference.

[0052] It should be understood that although the alignment ridge 214 is shown extending away from the first end 203 of the elastomeric valve, the present application contemplates that the alignment ridge may also be shaped as either a concave and / or convex surface extending from either the first and / or second ends 203, 204 of the elastomeric valve. In some embodiments of the present disclosure, the alignment ridge may be either a protrusion and / or an indentation along the perimeter 212 of the elastomeric valve.

[0053] The elastomeric valve 202 is positioned adjacent to the flow insert 302 to form another portion of the fluid flow path between the elastomeric valve 202 and the flow restrictor 100. To form a portion of the fluid flow path of the flow restrictor 100, the flow insert 302 has an inner surface that defines a fluid passage therethrough. The fluid passage includes a first section 306 and a second section 308. The first section 306 is defined by an outer surface 310 of the flow insert, and the second section 308 is defined by an inner surface 312 of the flow insert.

[0054] In some embodiments of the present disclosure, outer surface 310 is formed by a distal-most surface of flow insert 302 configured to forcibly engage at least a portion of elastomeric valve 202. Outer surface 310 may be shaped as a flat surface configured to forcibly engage the elastomeric valve to form a portion of the flow path therebetween.

[0055] First section 306 is formed by a channel extending in outer surface 310 and along a direction extending from the outer peripheral portion of the flow insert toward longitudinal axis BB defined by passageway second section 308. Outer surface 310 may define a transverse plane relative to longitudinal axis BB.

[0056] A first segment 306 of the fluid passageway of the flow insert extends in a non-linear direction along the outer surface 310 to form a spiral or involute shape in a direction toward the longitudinal axis BB. The first segment 306 of the passageway may be further defined by a first end 313 disposed adjacent the outer peripheral portion of the flow insert and a second end 314 that intersects with the second segment 308 of the passageway.

[0057] The first segment 306 of the fluid passageway may have a length between a first end 313 and a second end 314 and a width across the length. In some embodiments of the present disclosure, the length of the first segment 306 is approximately 1 inch (25.4 mm) and the width of the first segment 306 is approximately 0.02 inch (0.51 mm).

[0058] In some embodiments of the present disclosure, a portion of the fluid passageway of the flow insert 302 is formed by a groove 316 that extends to the outer surface 310 of the flow insert and extends between the first section 306 and the second section 308 of the fluid passageway. The groove 316 may be configured to allow fluid movement between the first section 306 and the second section 308 of the fluid passageway when the elastomeric valve 202 is moved or deflected toward the flow insert 302.

[0059] The flow insert 302 may further include an alignment channel 318 configured to receive the alignment ridge 214 of the elastomeric valve therein. In some embodiments of the present disclosure, the alignment ridge 214 and the alignment channel 318 are positioned on the elastomeric valve 202 and the flow insert 302, respectively, such that the aperture 210 of the elastomeric valve is aligned with the first section 306 of the passageway, as shown by dashed line B2 in FIG.

[0060] 9, with continued reference to Figures 5-8, a cross-sectional view of flow restrictor 100 is shown with elastomeric valve 202 in a first position between proximal housing 112 and distal housing 114. Resilient valve 202 is oriented with second end 204 adjacent to or in forcing engagement with recessed surface 142 of the distal housing and first end 203 adjacent to or in forcing engagement with outer surface 310 of the flow insert.

[0061] Along the second end 204 of the elastomeric valve, an inner portion 206 is aligned with the passageway 128 of the distal housing 114, and an outer portion 208 is aligned with the flow channel 144. The space formed along the flow channel 144 of the distal housing and the elastomeric valve 202 define a portion of a fluid flow path. It should be understood that in some embodiments of the present disclosure, the flow channel can extend to the elastomeric valve, forming a space between the elastomeric valve and the distal housing that defines a portion of the fluid flow path.

[0062] The aperture 210 of the elastomeric valve is aligned with the flow channel 144 of the distal housing, thereby allowing fluid to travel through the elastomeric valve in a direction toward or away from the flow channel 144. The aperture 210 of the elastomeric valve may be aligned with the distal end 148 of the flow channel or along another portion of the flow channel 144. In some embodiments of the present disclosure, the aperture 210 is aligned with the distal end 148 of the flow channel when the alignment ridge 214 of the elastomeric valve is pressed against or positioned within the alignment channel 318 of the flow insert.

[0063] Along the first end 203 of the elastomeric valve, the outer portion 208 and the aperture 210 are aligned with the first section 306 of the passageway such that fluid can travel between the flow channel 144 and the first section 306 of the passageway by traveling through the aperture 210.

[0064] It should be understood that in some embodiments of the present disclosure, the aperture 210 may be formed as a channel or groove along the periphery 212 of the elastomeric valve. Additionally, in some embodiments of the present disclosure, a portion of the fluid flow path extends around the periphery 212 of the elastomeric valve instead of or in addition to extending through the elastomeric valve.

[0065] The elastomeric valve inner portion 206 is aligned with the second section 308 of the passageway to form a portion of the fluid flow path therebetween. When the elastomeric valve 202 is in the first position, the elastomeric valve inner portion 206 is spaced a distance D1 from the flow insert, thereby allowing fluid to travel along the fluid flow path between the elastomeric valve 202 and the flow insert 302. In some embodiments of the present disclosure, the convex surface of the inner portion 206 defines a shoulder 207 configured to forcibly engage a valve seat 307 of the flow insert, where the valve seat 307 is between the first section 306 and the second section 308 of the passageway.

[0066] The fluid flow path through the flow restrictor 100 when the elastomeric valve 202 is in the first position is shown in FIG. 9. A fluid, such as blood, can travel through the distal port 124 of the distal housing (arrow A1). The fluid travels along the passageway 128 toward the flow channel 144 of the distal housing. The fluid can then travel along the flow channel 144 toward the aperture 210 of the elastomeric valve 202 (arrow A2). The fluid travels through the aperture 210 (arrow A3) and enters the first segment 306 of the fluid passageway for the flow insert 302.

[0067] 9 and 10, fluid may enter a first end 313 of a first segment 306 of the fluid passageway, the location of which is indicated by reference by dashed line B2. The fluid then travels along the first segment along a helical or involute-shaped path toward a second segment 308 of the passageway.

[0068] When the elastomeric valve 202 is in the first position, fluid can travel between the inner portion 206 of the elastomeric valve and the flow insert 302 to the second section 308 of the passageway. The fluid then travels along the second section 308 toward the proximal port 164 (arrow A5).

[0069] The elastomeric valve 202 is configured to respond to changes in pressure within a fluid flow path through the flow restrictor 100. For example, the elastomeric valve 202, or a portion thereof, may respond to changes in pressure within the fluid flow path by moving or deflecting relative to another portion of the elastomeric valve or the flow restrictor 100. Changes in pressure within the fluid flow path may exert pressure on the elastomeric valve 202, thereby causing the elastomeric valve 202 to deflect or stretch.

[0070] When the suction pressure at the proximal port 164 exceeds a certain value or range, the inner portion 206 of the elastomeric valve is biased or stretched toward the flow insert 302 such that the elastomeric valve 202 is in a second position. The second position of the elastomeric valve 202 is shown in FIG. 11.

[0071] In the second position, the elastomeric valve 202 is biased or stretched toward the flow insert 302 to resist or stop the flow of fluid through the fluid flow path of the flow restrictor 100. In some embodiments of the present disclosure, the shoulder 207 of the elastomeric valve is spaced from the valve seat 307 of the flow insert by a distance D2 that is less than D1 when the elastomeric valve 202 is in the second position. In some embodiments of the present disclosure, the distance D2 is zero such that movement of fluid through the flow restrictor 100 is prevented.

[0072] When the elastomeric valve 202 is in the second position, the flow of fluid through the fluid flow path is reduced or stopped, thereby reducing the pressure on the fluid. If the fluid traveling through the fluid flow path is blood, the reduced pressure may reduce homolysis on the blood.

[0073] In some embodiments of the present disclosure, when pressure along the fluid flow path applies a force of approximately 0.03 Newtons to the elastomeric valve 202, the elastomeric valve 202 moves from the first position toward the second position. In some embodiments, the elastomeric valve 202 is configured such that when a force of approximately 0.03 Newtons is applied to the elastomeric valve 202, a portion of the elastomeric valve, such as the inner portion 206, is displaced or deflected between approximately 0.03 mm and approximately 0.1 mm. In some embodiments, the elastomeric valve 202 is configured such that when a force of approximately 0.09 Newtons is applied to the elastomeric valve 202, a portion of the elastomeric valve, such as the inner portion 206, is displaced or deflected between approximately 0.1 mm and approximately 0.15 mm.

[0074] In some embodiments of the present disclosure, the resilient valve 202, or portions thereof, are made of an elastomeric material such as silicone. Any of the proximal and distal housings 112, 114 and the flow insert 302 may comprise a thermoplastic polymer material such as polycarbonate.

[0075] Description of the subject technology as a clause The subject technology is described according to various aspects, for example, as set forth below. Various examples of aspects of the subject technology are described as numbered clauses (1, 2, 3, etc.) for convenience. These are provided as examples and are not intended to limit the subject technology. Any of the dependent clauses can be combined in any combination and placed into their own independent clauses, e.g., clause 1 or clause 5. Other clauses can be presented in a similar manner.

[0076] Clause 1. A proximal housing including a first end portion forming a proximal port, a second end portion, and a passage extending through the first end portion and the second end portion; a distal housing including the first end portion, a second end portion forming a distal port, and a passage extending through the first end portion and the second end portion; a flow insert positioned within a cavity formed between the proximal housing and the distal housing and including a fluid passage extending therethrough, the fluid passage including a first section formed by an outer surface of the flow insert and a second section formed by an inner surface of the flow insert; and a flow insert positioned between the outer surface of the flow insert and the distal housing, having an inner portion and an outer portion. a compliant valve including a first end having an inner portion aligned with a second segment of the fluid passage of the flow insert and an outer portion aligned with the first segment of the fluid passage of the flow insert, wherein the inner portion of the compliant valve is flexible relative to the proximal housing such that in the first position of the compliant valve, the inner portion is spaced a first distance from the flow insert to allow fluid movement between the first and second segments of the fluid passage, and in the second position, the inner portion is spaced a second distance from the flow insert to prevent fluid movement between the first and second segments of the fluid passage.

[0077] Clause 2. The flow restrictor of Clause 1, wherein the second segment of the fluid passage defines an axis therethrough and the first segment of the fluid passage extends about the axis.

[0078] Clause 3. The flow restrictor of any one of clauses 1 and 2, wherein the first segment of the fluid passage extends radially outward in a helical direction away from the second segment of the fluid passage.

[0079] Clause 4. The flow restrictor of any one of Clauses 1 to 3, wherein a first segment of the fluid passage is formed by a channel extending into an outer surface of the flow insert.

[0080] Clause 5. The flow restrictor of Clause 4, wherein an outer surface of the flow insert extends along a plane transverse to an axis passing through the second segment of the fluid passage.

[0081] Clause 6. The flow restrictor of any one of Clauses 1 to 5, wherein the flow insert includes a groove extending to an outer surface of the flow insert between the first segment and the second segment of the fluid passage.

[0082] Clause 7. The flow restrictor of any one of clauses 1 to 6, wherein the first end of the elastomeric valve forms a convex surface along an inner portion and the second end of the elastomeric valve forms a concave surface along an inner portion.

[0083] Clause 8. The flow restrictor of any one of clauses 1 to 1, wherein the elastomeric valve includes an aperture extending through the outer portion from the first end to the second end of the elastomeric valve.

[0084] Clause 9. The flow restrictor device of Clause 8, wherein the distal housing includes a flow channel extending along the second end portion, the flow channel having a proximal end intersecting the passageway of the distal housing, and a distal end, the distal end of the flow channel being aligned with the aperture of the elastomeric valve.

[0085] Clause 10. The flow restrictor of any one of clauses 1 to 9, wherein the elastomeric valve includes an alignment ridge extending from the first end in a direction away from the second end.

[0086] Article 11. 1. A flow restricting device comprising: a flow insert including a fluid passage extending therethrough, the fluid passage including a first section defined by an outer surface of the flow insert and a second section defined by an inner surface of the flow insert; and a elastomeric valve including a first end forcibly engaged with the outer surface of the flow insert and an aperture extending therethrough from the first end to a second end of the elastomeric valve, the first end having an inner portion aligned with the second section of the fluid passage and an outer portion aligned with the first section of the fluid passage, the inner portion of the elastomeric valve being flexible relative to the flow insert such that in a first orientation of the elastomeric valve, the inner portion is spaced a first distance from the flow insert to allow fluid movement between the first and second sections of the fluid passage, and in a second orientation of the elastomeric valve, the inner portion is spaced a second distance from the flow insert to prevent fluid movement between the first and second sections of the fluid passage.

[0087] Clause 12. The flow restrictor of Clause 11, wherein the second segment of the fluid passage defines an axis therethrough and the first segment of the fluid passage extends about the axis.

[0088] Clause 13. The flow restrictor of any one of clauses 11 and 12, wherein the first section of the fluid passage extends radially outward in a helical direction away from the second section of the fluid passage.

[0089] Clause 14. The flow restrictor of any one of Clauses 11 to 13, wherein the first segment of the fluid passage is formed by a channel extending into the outer surface of the flow insert.

[0090] Clause 15. The flow restrictor of Clause 14, wherein an outer surface of the flow insert extends along a plane transverse to an axis passing through the second segment of the fluid passage.

[0091] Clause 16. The flow restrictor device of any one of Clauses 11 to 15, wherein the flow insert includes a groove extending to an outer surface of the flow insert between the first segment and the second segment of the fluid passage.

[0092] Clause 17. The flow restrictor of any one of clauses 11 to 16, wherein the first end of the elastomeric valve forms a convex surface along an inner portion and the second end of the elastomeric valve forms a concave surface along an inner portion.

[0093] Clause 18. The flow restrictor of any one of clauses 11 to 17, wherein the aperture extends through an outer portion of the elastomeric valve.

[0094] Clause 19. The flow restrictor of any one of clauses 11 to 18, wherein the aperture of the elastomeric valve is aligned with the first section of the fluid passageway.

[0095] Clause 20. The flow restrictor of any one of Clauses 11 to 19, wherein the elastomeric valve includes an alignment ridge extending from the first end in a direction away from the second end.

[0096] This disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. While this disclosure provides various examples of the subject technology, the subject technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects.

[0097] Reference to an element in the singular is not intended to mean "one and only one" unless specifically so stated, but rather "one or more." The term "some" refers to one or more unless specifically stated otherwise. Pronouns referring to the masculine (e.g., his) include the feminine and neuter (e.g., her and its) and vice versa. Headings and subheadings, if any, are used for convenience only and do not limit the invention.

[0098] The word "exemplary" is used herein to mean "serving as an example or illustration." Any aspect or design described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other aspects or designs. In one aspect, various alternative configurations and operations described herein may be considered at least equivalent.

[0099] As used herein, the phrase "at least one of" preceding a list of items modifies the list as a whole, rather than each item in the list, with the word "or" used to separate any of the items. The phrase "at least one of" does not require the selection of at least one item, but rather allows the phrase to mean including at least one item of any of the items, and / or at least one combination of any combination of the items, and / or at least one item of each of the items. Illustratively, the phrase "at least one of A, B, or C" can refer to A only, B only, or C only, or any combination of A, B, and C.

[0100] The use of a phrase such as "aspect" does not imply that such aspect is essential to the subject technology or that such aspect applies to all configurations of the subject technology. Disclosure of an aspect may apply to all configurations, or to one or more configurations. An aspect may provide one or more examples. A phrase such as "aspect" may refer to one or more aspects, and vice versa. A phrase such as "embodiment" does not imply that such an embodiment is essential to the subject technology or that such an embodiment applies to all configurations of the subject technology. Disclosure of an embodiment may apply to all embodiments, or to one or more examples. An embodiment may provide one or more examples. A phrase such as "embodiment" may refer to one or more examples, and vice versa. A phrase such as "configuration" does not imply that such a configuration is essential to the subject technology or that such a configuration applies to all configurations of the subject technology. Disclosure of a configuration may apply to all configurations, or to one or more configurations. A configuration may provide one or more examples. A phrase such as a configuration can refer to one or more configurations, and vice versa.

[0101] In one aspect, unless otherwise stated, all measurements, values, ratings, locations, dimensions, sizes, and other specifications set forth herein, including those contained in the claims that follow, are approximate and not precise, and are intended to have a reasonable range consistent with the functions to which they relate and with what is customary in the technical field to which they pertain.

[0102] It is understood that the specific order or hierarchy of steps or operations in the disclosed processes or methods is an illustration of an example approach. It is understood that the specific order or hierarchy of steps, operations, or operations may be rearranged based on implementation preferences or scenarios. Some of the steps, operations, or operations may be performed simultaneously. In some implementation preferences or scenarios, certain operations may or may not be performed. Some or all of the steps, operations, or operations may be performed automatically without user intervention. The accompanying method claims present elements of the various steps, operations, or operations in a sample order, and are not meant to be limited to the specific order or hierarchy presented.

[0103] All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known, or that later become known, to those skilled in the art are intended to be expressly incorporated herein by reference and encompassed by the claims. Moreover, nothing disclosed herein is intended to be made available to the public, regardless of whether such disclosure is expressly recited in the claims. No element of a claim is to be construed under the provisions of 35 U.S.C. § 112(f) unless the element is expressly recited using the phrase "means for," or, in the case of a method claim, unless the element is recited using the phrase "step for." Furthermore, to the extent the terms "comprise," "have," and the like are used, such terms are intended to be inclusive in the same manner as the term "comprise," as "comprises" is interpreted when used as a transitional word in a claim.

[0104] The title, background art, summary, brief description of the drawings, and abstract of this disclosure are hereby incorporated into this disclosure and are provided as illustrative examples of the disclosure, not as a limiting description. This disclosure is submitted with the understanding that they are not used to limit the scope or meaning of the claims. Furthermore, in the Detailed Description, it is understood that the description provides illustrative examples, and that various features have been grouped together in various embodiments to streamline the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that claimed subject matter requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed structure or operation. The following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as separately claimed subject matter.

[0105] The claims are not intended to be limited to the embodiments described herein, but are to be accorded full scope consistent with the language of the claims and encompass all legal equivalents. However, none of the claims are intended, and should not be construed, to cover subject matter that does not satisfy the requirements of 35 U.S.C. §§ 101, 102, or 103.

Claims

1. a proximal housing defining a proximal passageway, a distal housing defining a distal passageway, and a cavity defined between the proximal housing and the distal housing; a flow insert that defines a valve seat and at least a portion of a fluid passageway between the proximal passageway and the distal passageway, the portion of the fluid passageway having a first section and a second section along the flow insert; an elastomeric valve including a first end having an inner portion and an outer portion, the elastomeric valve positioned between the flow insert and the distal housing such that the first segment of the fluid passage is defined between the outer portion of the elastomeric valve and the flow insert, the elastomeric valve including a first position and a second position, in the first position the elastomeric valve is spaced from the valve seat to allow fluid movement from the first segment to the second segment of the fluid passage, and in the second position the elastomeric valve is forcibly engaged against the valve seat to prevent movement of the fluid between the first and second segments of the fluid passage; a flow restricting device,

2. 2. The flow restricting device of claim 1, wherein the valve seat is between the first and second sections of the fluid passageway.

3. The flow restricting device of claim 1 , wherein the second segment of the fluid passage defines an axis therethrough and the first segment of the fluid passage extends about the axis.

4. The flow restricting device of claim 1 , wherein the first section of the fluid passage extends radially outward in a spiral direction away from the second section of the fluid passage.

5. 2. The flow restrictor of claim 1, wherein the first section of the fluid passage is defined by a channel extending into an outer surface of the flow insert.

6. The flow restrictor of claim 5 , wherein the outer surface of the flow insert extends along a plane transverse to an axis passing through the second segment of the fluid passage.

7. 2. The flow restrictor of claim 1, wherein the flow insert includes a groove extending to an outer surface of the flow insert between the first and second sections of the fluid passage.

8. 2. The flow restricting device of claim 1, wherein the first end of the elastomeric valve defines a convex surface along the inner portion and the second end of the elastomeric valve defines a concave surface along the inner portion.

9. 2. The flow restricting device of claim 1, wherein the distal housing includes a flow channel having a proximal end that intersects with the distal passage of the distal housing and a distal end that is fluidly connected to the first section of the fluid passage.

10. 2. The flow restricting device of claim 1, wherein the resilient valve includes an alignment ridge extending from the first end in a direction toward the flow insert.

11. 2. The flow restricting device of claim 1, wherein the elastomeric valve is configured to move from the first position to the second position when a fluid pressure on the elastomeric valve is greater than 0.03 Newtons.

12. 10. The flow restricting device of claim 1, wherein the elastomeric valve moves from the first position to the second position and the inner portion of the elastomeric valve is deflected between 0.03 mm and approximately 0.10 millimeters.

13. 10. The flow restricting device of claim 1, wherein the inner portion of the elastomeric valve is displaced between 0.10 mm and approximately 0.15 mm when the elastomeric valve moves from the first position to the second position.

14. The flow restricting device of claim 1 , wherein an aperture extends through the outer portion of the elastomeric valve.

15. 1. A method of providing a flow restrictor, the method comprising: providing a proximal housing forming a proximal passageway and a distal housing forming a distal passageway, a cavity being formed between the proximal and distal housings; providing a flow insert between the proximal housing and the distal housing; providing a resilient valve between the flow insert and the distal housing, such that a first segment of a fluid passageway is formed between an outer portion of the resilient valve and the flow insert, and such that a second segment of the fluid passageway is formed between the first segment and the proximal passageway; Including, an inner portion of the elastomeric valve is movable between a first position and a second position, wherein in the first position the elastomeric valve is spaced from a valve seat of the flow insert to allow fluid movement from the first segment to the second segment of the fluid passage, and in the second position the elastomeric valve is forcibly engaged against the valve seat to prevent movement of the fluid between the first and second segments of the fluid passage.

16. 16. The method of claim 15, wherein the elastomeric valve is configured to move from the first position to the second position when a fluid pressure on the elastomeric valve is greater than 0.03 Newtons.

17. 16. The method of claim 15, wherein the elastomeric valve moves from the first position to the second position, and the inner portion of the elastomeric valve is deflected between 0.03 mm and approximately 0.10 millimeters.

18. 16. The method of claim 15, wherein providing the flow insert between the proximal housing and the distal housing comprises positioning the flow insert within a cavity formed between the proximal housing and the distal housing.

19. 16. The method of claim 15, wherein forming the elastic valve between the flow insert and the distal housing includes positioning the elastic valve with the inner portion extending into the second section of the fluid passage.

20. 16. The method of claim 15, wherein providing the elastic valve between the flow insert and the distal housing includes aligning the inner portion of the elastic valve with the second section of the fluid passage and aligning the outer portion of the elastic valve with the first section of the fluid passage.

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